Delivery systems and methods for sheathing and deploying an implantable device

ABSTRACT

Systems and methods are disclosed for delivering a stent to a lumen internal to a body of a patient and for sheathing a stent just prior to an insertion procedure. One embodiment comprises a delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration. A panchor (combination pusher and anchor) is configured to engage and limit proximal and distal movement of the implantable device. An outer sheath surrounds a distal portion of an inner member and retains the implantable device near the distal end. The outer sheath is slidably moveable relative to the inner member to deploy the implantable device. Proximal movement of a trigger results in movement of the outer sheath to deploy the implantable device. A sheathing mechanism is configured to crimp and fully sheathe the implantable device prior to a deployment procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/553,844, entitled “STENT DELIVERYSYSTEMS AND METHODS,” filed Oct. 31, 2011, and U.S. Provisional PatentApplication No. 61/596,473, entitled “STENT DELIVERY SYSTEMS ANDMETHODS,” filed Feb. 8, 2012, each of which is hereby incorporatedherein by reference in its entirety.

TECHNICAL FIELD

The present disclosure is directed to systems and methods for deliveringa stent to a lumen internal to a body of a patient, and moreparticularly to systems and methods for sheathing a stent just prior toan insertion procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain suchillustrative embodiments that are depicted in the figures, in which:

FIG. 1 is a perspective view of a stent delivery system in a partiallysheathed configuration, according to one embodiment of the presentdisclosure.

FIG. 2 is a closer perspective view of the stent delivery system of FIG.1 in a fully sheathed delivery configuration.

FIG. 3 is an exploded view of the stent delivery system of FIG. 1.

FIG. 4A is a side view of the stent delivery system of FIG. 1.

FIG. 4B is a cut-away, cross-sectional side view of the stent deliverysystem of FIG. 4A.

FIG. 4C is another cut-away, cross-sectional side view of the stentdelivery system of FIG. 4A.

FIG. 4D1 is another cut-away, cross-sectional side view of the stentdelivery system of FIG. 4A.

FIG. 4D2 is an enlargement of the cut-away, cross-sectional side view ofFIG. 4D1.

FIG. 5A is a perspective view illustrating assembly of a sheathingmechanism at a distal region of the stent delivery system of FIG. 1,preparatory to performing a stent implantation procedure.

FIG. 5B is a perspective view illustrating assembly of a sheathingmechanism at a distal region of the stent delivery system of FIG. 1.

FIG. 5C is another perspective view illustrating assembly of a sheathingmechanism at a distal region of the stent delivery system of FIG. 1.

FIG. 5D is a perspective view illustrating the stent delivery system ofFIG. 1 in a partially sheathed configuration with a fully assembledsheathing mechanism.

FIG. 5E1 is a perspective view illustrating the stent delivery system ofFIG. 1, preparatory to sheathing.

FIG. 5E2 is an end view of a distal end of the stent delivery system ofFIG. 5E1.

FIG. 5F1 is a perspective view illustrating a beginning of a sheathingaction of the stent delivery system of FIG. 1, preparatory to performinga stent implantation procedure.

FIG. 5F2 is an end view of a distal end of the stent delivery system ofFIG. 5F1.

FIG. 5F3 is a cross-sectional side view of a distal end of the stentdelivery system of FIG. 5F1.

FIG. 5G1 is a perspective view further illustrating a sheathing actionof the stent delivery system of FIG. 1.

FIG. 5G2 is an end view of a distal end of the stent delivery system ofFIG. 5G1.

FIG. 5G3 is an enlarged cross-sectional side view of a distal end of thestent delivery system of FIG. 5G1.

FIG. 5H is a perspective view illustrating disassembly of the sheathingmechanism of the stent delivery system of FIG. 1, preparatory toperforming a stent implantation procedure.

FIG. 5I is another perspective view of the sheathing mechanism of thestent delivery system of FIG. 1 in a fully sheathed deliveryconfiguration, preparatory to performing a stent implantation procedure.

FIG. 6A1 is a side view of the stent delivery system of FIG. 1 in apartially sheathed configuration and in a similar configuration as inFIG. 5E1.

FIG. 6A2 is an enlarged cross-sectional side view of a distal region ofthe stent delivery system of FIG. 6A1.

FIG. 6B1 is a side view of the stent delivery system of FIG. 1 in apartially sheathed configuration and in a similar configuration as inFIG. 5F1.

FIG. 6B2 is an enlarged, cross-sectional side view of a distal region ofthe stent delivery system of FIG. 6B1.

FIG. 6C1 is a side view of the stent delivery system of FIG. 1 in apartially sheathed configuration and in a similar configuration as inFIG. 5G1.

FIG. 6C2 is an enlarged, cross-sectional side view of a distal region ofthe stent delivery system of FIG. 6C1.

FIG. 6D1 is a side view of the stent delivery system of FIG. 1 in afully sheathed configuration and in a similar configuration as in FIG.5I.

FIG. 6D2 is an enlarged, cross-sectional side view of a distal region ofthe stent delivery system of FIG. 6D1.

FIG. 7A is a side longitudinal cross-sectional view of the stentdelivery system of FIG. 1 in the fully sheathed delivery configuration.

FIG. 7B is a close-up, cross-sectional view the stent of the stentdelivery system of FIG. 7A in a compressed configuration.

FIG. 8A1 is a side longitudinal cross-sectional view of the stentdelivery system of FIG. 1 with the trigger safety removed.

FIG. 8A2 is a close-up, cross-sectional view of the fully sheathed stentof the stent delivery system of FIG. 8A1.

FIG. 8B1 is a side longitudinal, cross-sectional view of the stentdelivery system of FIG. 1 with the proximal trigger retracted.

FIG. 8B2 is a close-up, cross-sectional view of the partially deployedstent of the stent delivery system of FIG. 8B1.

FIG. 8C1 is a side longitudinal, cross-sectional view of the stentdelivery system of FIG. 1 with the distal trigger retracted.

FIG. 8C2 is a close-up, cross-sectional view of the stent of the stentdelivery system of FIG. 8C1.

FIG. 8D is a close-up, side longitudinal, cross-sectional view of thestent delivery system of FIG. 1 with the stent in a fully expanded,deployed state.

FIG. 9A is a transverse cross-sectional view of a portion of the stentdelivery system of FIG. 1.

FIG. 9B is a longitudinal, cross-sectional view of a portion of thestent delivery system of FIG. 1.

FIG. 10A is end view of a proximal trigger of the stent delivery systemof FIG. 1.

FIG. 10B is an end view of a distal trigger of the stent delivery systemof FIG. 1.

FIG. 11A is a side view of an internal connector, a distal trigger, afloater, and a proximal trigger of the stent delivery system of FIG. 1.

FIG. 11B is a top cross-sectional view of an internal connector, adistal trigger, a floater, and a proximal trigger of the stent deliverysystem of FIG. 1.

FIG. 12A is a perspective view of the sheathing funnel and sheathingtube of the stent delivery system of FIG. 1.

FIG. 12B is an end view of the sheathing funnel of the stent deliverysystem of FIG. 1.

FIG. 12C is a perspective view of the sheathing funnel of the stentdelivery system of FIG. 1.

FIG. 13A is a perspective view of the trigger safety of the stentdelivery system of FIG. 1.

FIG. 13B is a side view of the trigger safety of the stent deliverysystem of FIG. 1 in a closed state.

FIG. 13C is a side view of the trigger safety of the stent deliverysystem of FIG. 1 in an open state.

FIG. 14A is a perspective view of a panchor of the stent delivery systemof FIG. 1.

FIG. 14B is another perspective view of a panchor of the stent deliverysystem of FIG. 1.

FIG. 14C is a side view of a panchor of the stent delivery system ofFIG. 1.

FIG. 14D is a top view of a panchor of the stent delivery system of FIG.1.

FIG. 14E is a bottom view of a panchor of the stent delivery system ofFIG. 1.

FIG. 14F is an end view of a panchor of the stent delivery system ofFIG. 1.

FIG. 14G is another end view of a panchor of the stent delivery systemof FIG. 1.

FIG. 14H is a cross-sectional view of a panchor of the stent deliverysystem of FIG. 1.

FIG. 15A is a perspective view of a tip insertion funnel of the stentdelivery system of FIG. 1.

FIG. 15B is another perspective view of a tip insertion funnel of thestent delivery system of FIG. 1 in a closed state.

FIG. 15C is a perspective view of a tip insertion funnel of the stentdelivery system of FIG. 1 in an open state.

FIG. 16A is a perspective view of a stent delivery system having threetriggers in a partially sheathed configuration, according to anotherembodiment of the present disclosure.

FIG. 16B is a perspective view of the stent delivery system of FIG. 16Ain a fully sheathed delivery configuration.

FIG. 17A is a side view of an internal connector, a third trigger, afloater, a second trigger, external floater arms, and a first trigger ofthe stent delivery system of FIGS. 16A and 16B.

FIG. 17B is a top cross-sectional view of an internal connector, a thirdtrigger, a floater, a second trigger, external floater arms, and a firsttrigger of the stent delivery system of FIGS. 16A and 16B.

FIG. 18A is a side view of a panchor of the stent delivery system ofFIGS. 16A and 16B.

FIG. 18B is a side cross-sectional view of the panchor of the stentdelivery system of FIGS. 16A and 16B.

FIG. 18C is a side cross-sectional view illustrating flexibility of thepanchor of the stent delivery system of FIGS. 16A and 16B.

FIG. 19 is a perspective view of a packaged stent delivery system in astorage configuration, according to one embodiment.

DETAILED DESCRIPTION

The present disclosure relates to systems and methods for deploying acrimpable implantable device within a body of a patient. For example,the disclosed systems and methods may provide for deploying a valvedstent within a lumen of a body of a patient. The disclosed embodimentsmay allow the implantable device to be stored and/or transported inpartially sheathed (and also partially deployed) storage configuration,such that a portion of the implantable device is crimped and/or sheathedwithin a stent delivery device. A portion of the implantable device mayalso remain unsheathed and in an expanded (or uncrimped) state. In thecase of a valved stent, the portion of the valved stent that includesthe valve can remain unsheathed in an expanded state to prevent thevalve from enduring prolonged periods of compression and deformation(e.g., during storage and/or transport) that can result in deformationof the valve.

The disclosed embodiments may further allow a practitioner to fullycrimp and/or fully sheathe the implantable device and transition thedelivery device into a delivery configuration just prior to delivery ofthe implantable device to a desired location within a target lumen. Thedisclosed embodiments may further allow deployment of the implantabledevice to an expanded fully deployed state.

Implantable medical devices are valuable tools of modern medicine. Ingeneral, an implantable device is a device or structure configured to beinserted or embedded into a patient for a variety of functions.Implantable devices include stents, filters, markers, drug deliverydevices, valves, and monitors.

Stents are implantable devices that are inserted into body lumina, suchas vessels or passages, to keep the lumen open and prevent closure dueto a stricture, external compression, or internal obstruction. Stentsare commonly used to keep blood vessels open in the coronary arteries,and they are frequently inserted into the ureters to maintain drainagefrom the kidneys, the bile duct for pancreatic cancer orcholangiocarcinoma, or the esophagus or airways for strictures orcancer.

In order to serve a desired function, an implantable device should bedelivered precisely and oriented correctly. Improper installation canlead to several adverse complications, including tissue luminalinflammation and tissue granulation. In order to facilitate the deliveryof implantable devices, delivery devices, such as endoscopes andcatheters, have been utilized to deploy implantable devices moreprecisely.

Delivery devices vary in shape and structure. However, in general, adelivery device may include a handle and one or more movable tubularmembers extending from the handle. The delivery device may furtherinclude a deployment mechanism for moving or operating the tubularmembers between positions. The one or more moveable tubular memberstypically include an inner tubular member disposed within an outertubular member or sheath. The outer tubular member is typically shorterthan the inner tubular member and movable relative to the inner tubularmember. A distal region of the outer tubular member generally surroundsthe implantable device. In the case of a stent, the outer tubular membermay maintain the stent sheathed in a crimped state in the sheatheddelivery configuration, while a distal region of the inner tubularmember is surrounded by the stent. Once the sheathed stent is properlypositioned at a target deployment site, the outer tubular member may beretracted to deploy the stent and allow the stent to radially expand.

Many presently available delivery devices require an implantable deviceto be fully crimped and/or sheathed by special equipment prior tostorage and/or transport and prior to deployment for use, for example intreating a lumen of a body of a patient. As used herein, the terms“crimp” and “crimping” refer to compressing or drawing a crimpableimplantable device inward, radial toward a longitudinal axis of theimplantable device, to bring the implantable device to approximately anoriginal or initial size. Crimping may occur independent from and withlimited compression or expansion longitudinally along a longitudinalaxis of the implantable device. In other words, crimping may involvelimited or no change in a longitudinal dimension of the implantabledevice.

Some implantable devices are designed to be sheathed (or re-sheathed)for removal from the body, yet such implantable devices may beconfigured such that they cannot be subsequently deployed for usewithout properly being crimped before being sheathed. A stent that isre-sheathed may not necessarily be crimped or otherwise returned to acrimped state. The re-sheathing process may damage, deform, or otherwisealter the structural integrity or other characteristic of theimplantable device in such a way as to limit the usability of theimplantable device when subsequently deployed, thereby preventingsubsequent use.

Sheathing some implantable devices in a manner that avoids damage to thestructural integrity of the stent, to enable subsequent use, can beparticularly challenging. For example, some embodiments of stents, suchas are disclosed in U.S. patent application Ser. No. 13/153,150,entitled “ESOPHOGEAL STENT,” which is hereby incorporated by referenceherein in its entirety, may comprise a support or scaffolding structureformed of a plurality of rows of struts or legs oriented about an outercircumference of the stent and connected by a plurality of connectorsextending longitudinally with a longitudinal axis of the stent.Additionally, the stent or other implantable device may comprise avariety of components, and the parameters of these components—such asshape, length, thickness, position, etc.—may greatly vary to provide astent with certain properties. The arrangement of these components maymake sheathing of the stent quite difficult. Protruding components ofthe scaffolding structure may prevent the stent, or portions of thestent from being “self-sheathing” with traditional equipment. Thecomponents may need to be crimped prior to sheathing. Prior to theembodiments of the present disclosure, such embodiments of stents couldnot be crimped and/or sheathed outside of a factory setting in a mannerthat would render the stent in a useable state for subsequent deploymentand use.

Traditional delivery devices, which require that the implantable devicebe fully crimped and sheathed prior to storage and/or transport foreventual use, can be problematic to use to deliver (or deploy) a valvedstent. A valve of a valved stent may be formed of a polymer materialthat may be easily deformable by applying a constant force or otherwisemaintaining the valve in a deformed state for a prolonged period oftime.

For example, embodiments of a valved stent are disclosed in U.S. patentapplication Ser. No. 13/285,358, entitled “ESOPHOGEAL STENT WITH VALVE,”which is hereby incorporated by reference herein in its entirety, andmay include a valve formed of a polymer. Because polymers lack a welldefined crystalline structure, they can easily undergo a glasstransition at a given glass transition temperature T_(g) when cooled (orheated) and, thereby, exhibit physical properties of both a solid and aliquid. Specifically, a polymer can be cooled into a desired shape andmay hold that shape. However, the polymer can easily be reshaped orplastically deformed in response to pressure or stress, particularly ifalso exposed to temperatures approaching or above the T_(g) of thepolymer. If the T_(g) is relatively low (e.g., 114 degrees F.), as inthe case for some polymers, plastic deformation occurs easily. A polymervalve of a valved stent that is compressed and deformed in a deliveryconfiguration of the stent for a prolonged period of time (e.g., duringstorage and/or transport) can permanently deform. The deformed valve maynot function properly and thus remain in a defective and unusable state.Accordingly, a delivery device that can only be used by a practitionerif the stent arrives fully crimped and/or sheathed may not be aneffective delivery device for a valved stent. A delivery device that canbe transported with the valve in a natural operable configuration, andnot subject to forces that may induce plastic deformation, may bedesirable.

Also, because delivery devices are commonly designed to facilitate easydeployment, inadvertent or accidental deployment may easily occur.Safety mechanisms to secure the outer tubular member relative to theinner tubular member typically comprise a pin passing through both theouter tubular member and the inner tubular member. These “pin-type”safety mechanisms can be difficult to operate or even ineffective insome instances. For example, a “pin-type” safety mechanism does notallow distal movement of a trigger and/or an outer sheath to enablesheathing a stent, while also restricting proximal movement of thetrigger to prevent inadvertent deployment.

The present disclosure is directed to stent delivery systems addressingvarious shortcomings of presently available stent delivery devices. Inparticular, the present disclosure provides a stent delivery system thatmay enable a practitioner to fully sheath a stent that may be merelypartially sheathed or even completely unsheathed and in an expandedconfiguration. The stent delivery system may have a plurality oftriggers and a trigger safety to prevent accidental or inadvertentdeployment. A stent delivery system according to the present disclosuremay also have a flexible pusher/anchor (“panchor”) component configuredto engage the sheathed stent to restrict movement of the sheathed stentboth proximally and distally relative to the delivery device.

Although described in terms of delivering an esophageal stent with avalve, a person having ordinary skill in the art, with the aid of thepresent disclosure, will readily appreciate that the disclosed deliverysystems can be used to deliver a variety of crimpable implantabledevices, including but not limited to stents, filters, markers, drugdelivery devices, valves, and monitors. In one embodiment, the presentdisclosure provides an esophageal valved stent delivery system. Thepresent disclosure is also applicable to a variety of stents designedfor a variety of applications, for example, biliary stents, bronchialstents, tracheal stents, colonic/duodenal stents, and so on. In anotherembodiment, the present disclosure may provide a heart replacement valvedelivery system. In other embodiments, the present disclosure mayprovide a delivery system for other crimpable valves. In still otherembodiments, the present disclosure may provide a delivery system for avariety of crimpable devices.

The embodiments of the disclosure will be best understood by referenceto the drawings, wherein like parts are designated by like numeralsthroughout. It will be readily understood that the components of thedisclosed embodiments, as generally described and illustrated in thefigures herein, could be arranged and designed in a wide variety ofdifferent configurations. Thus, the following detailed description ofthe embodiments of the systems and methods of the disclosure is notintended to limit the scope of the disclosure, as claimed, but is merelyrepresentative of possible embodiments of the disclosure. In addition,the steps of a method do not necessarily need to be executed in anyspecific order, or even sequentially, nor need the steps be executedonly once, unless otherwise specified.

In some cases, well-known features, structures or operations are notshown or described in detail. Furthermore, the described features,structures, or operations may be combined in any suitable manner in oneor more embodiments. As will also be readily understood, the componentsof the embodiments as generally described and illustrated in the figuresherein could be arranged and designed in a wide variety of differentconfigurations.

The phrases “connected to,” “coupled to,” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be coupled to each other even thoughthey are not in direct contact with each other. For example, twocomponents may be coupled to each other through an intermediatecomponent.

The terms “proximal” and “distal” refer to opposite ends of a medicaldevice. As used herein, the proximal end of a medical device is the endnearest a practitioner during use, while the distal end is the oppositeend. For example, the proximal end of a stent delivery device refers tothe end having the handle and disposed nearest a point of contact withthe practitioner when the stent delivery device is in use by apractitioner.

FIG. 1 is a perspective view of a stent delivery system 100 in apartially sheathed configuration, according to one embodiment of thepresent disclosure. The stent delivery system 100 may comprise a stentdelivery device 101 and a sheathing mechanism 201. The stent deliverydevice 101 may comprise a trigger assembly 102 and a tubular member 104.The tubular member 104 is configured to house a crimped and/or sheathedstent 10 for delivery to a target location within a patient's body, suchas within a lumen. The trigger assembly 102 may enable a practitioner todeploy the stent 10. The sheathing mechanism 201 may enable apractitioner to fully sheath a partially sheathed stent 10 shortly priorto a procedure in which the stent 10 may be deployed in a lumen of apatient. In the illustrated embodiment, the stent 10 may be a valvedstent having a valve 12. The stent 10 may have a length, for example, of100 mm, such that it could be deployed with a two-stage, two-triggerdeployment mechanism.

The valved stent 10 may be an esophageal stent. Some patients sufferfrom an obstruction of the esophagus at or near the lower esophagealsphincter, which is the valve at the opening of the esophagus into thestomach. The lower esophageal sphincter prevents stomach acid and othergastric fluids from travelling up the esophagus, particularly when aperson is lying down or in a prone position. If a stent is positionednear or through the portion of the esophagus where the lower esophagealsphincter is located, the stent may prevent proper functioning of thelower esophageal sphincter. Without a prosthetic valve coupled in thestent to prevent migration of gastric fluids up the esophagus, thegastric fluids can work their way into the lungs, for example, while theperson is sleeping. An individual without a properly functioning valveat the opening between the stomach and esophagus can aspirate gastricfluids while sleeping in a recumbent or lying position (e.g., supine,prone, lateral recumbent) and die from asphyxiation. The stent 10 with avalve 12 can be positioned at the opening of the esophagus into thestomach and the valve 12 can function to allow food to pass in onedirection but prevent passage of gastric fluids in an oppositedirection.

The partially sheathed configuration of the stent delivery system 100may be a storage and/or transport configuration. A portion of the stent10 may remain uncrimped and/or unsheathed. The valve 12 may bepositioned in an uncrimped and/or an unsheathed portion of the stent 10that is in a partially sheathed configuration. The unsheathed portion ofthe stent 10 may remain in an uncrimped (or expanded) state. Therefore,the valve can be maintained in an operational or natural (e.g.,undeformed) state during, for example, storage and/or transport, untiljust before implantation of the stent 10 in a lumen of a patient. Also,the stent 10 may be partially sheathed to facilitate fully sheathing thestent 10 to transition to a fully sheathed delivery configuration.

FIG. 2 provides a closer perspective view of the stent delivery system100 in the fully sheathed delivery configuration. The tubular member 104of the stent delivery device 101 may include an outer sheath 126 coupledto the trigger assembly 102. The outer sheath 126 may include a pod 134at the distal end to enclose or sheathe the stent 10 in a crimped state.In FIG. 2, the stent 10 is not shown because it is fully crimped andfully sheathed within the pod 134. The trigger assembly 102 may includea plurality of triggers 114, 116 that are configured to be seriallyretracted (e.g., pulled) toward a handle 106 to retract the outer sheath126 and provide staged release (or deployment) of the stent 10. Thetriggers 114, 116 may be supported by outer supports 110. A proximaltrigger 114 may be pulled proximally, toward the handle 106, topartially deploy the stent. A distal trigger 116 may then be pulledproximally, toward the handle 106 and the proximal trigger 114, tocomplete deployment of the stent 10.

The serial retraction of proximal trigger 114 and then the distaltrigger 116 to provide a staged deployment of the stent 10 may occur ina manner such that retracting the proximal trigger 114 moves the distaltrigger 116 and the outer sheath 126 proximally and longitudinallyrelative to an inner member, from a first position to a second positionto partially unsheathe and deploy the stent 10. Subsequent retraction ofthe distal trigger 116 moves the outer sheath 126 proximally andlongitudinally relative to the inner member from the second position toa third position to fully unsheathe and deploy the stent 10. Deploymentof the stent 10 will be described in greater detail below with referenceto FIGS. 8A1-8A2, 8B1-8B2, 8C1-8C2, and 8D.

One or more trigger guide slots 150 in the outer supports 110 andcorresponding protrusions or trigger guides (not shown) on the triggers114, 116 may guide longitudinal movement of the triggers 114, 116. Atrigger safety 142 may inhibit operation of the trigger assembly 102 torestrict deployment of a sheathed stent 10. More specifically, thetrigger safety 142 may limit proximal movement of the proximal trigger114 and the distal trigger 116, thereby restricting deployment of thestent 10. By restricting proximal movement of the triggers 114, 116, thetrigger safety 142 may guard against inadvertent or accidentaldeployment of the stent 10.

A sheathing grip 112 may provide a handle that can be grasped duringsheathing of the stent 10. The sheathing grip 112 can be grasped with afirst hand while the sheathing mechanism 201 may be grasped with asecond hand. With the first hand, the sheathing grip 112 may be pulled,pushed, or otherwise forced away from the sheathing mechanism 201 duringa sheathing action to crimp and fully sheathe the stent 10. Similarly,the second hand may push, pull, or otherwise force the sheathingmechanism 201 away from the sheathing grip 112 during a sheathingaction.

The sheathing mechanism 201 is designed for the user to perform asheathing action to sheathe the stent 10. The sheathing action mayinitiate two actions relative to the stent 10. A first action is tocrimp the stent 10 to a diameter that approximates the inner diameter ofthe pod 134. By virtue of crimping, a second action of sliding the pod134 over the crimped stent 10 is facilitated. As can be appreciated, aportion of the stent 10, but less than all, may be crimped (orcompressed) at a given time and the pod 134 may be slid over (tosheathe) that portion before or while a next portion of the stent 10 maybe crimped. The crimping action need not be completed for the entirestent 10 prior to beginning the sliding of the pod 134. The stent 10 canbe gradually crimped and the sliding of the pod 134 may occur as thestent 10 is crimped, thereby gradually sheathing crimped portions of thestent 10. In other words, crimping and sheathing of the stent 10 mayoccur contemporaneously, or substantially contemporaneously, in a singlemotion and/or action.

The sheathing mechanism 201 may include a sheathing tube 202, asheathing funnel 204, sheathing fingers 206, a tip insertion funnel 208,and a tip 132. As will be described in more detail below, the componentsof the sheathing mechanism 201 are assembled at a distal end of thetubular member 104, around the distal end of the outer sheath 126 or thepod 134, and facilitate sheathing of the stent 104. The sheathing funnel204 and/or the sheathing tube interact with the sheathing fingers 206and/or the stent 10 to crimp the stent 10. The crimping of the stent 10compresses the stent 10 to a crimped configuration over which the pod134 can slide.

The sheathing tube 202 and/or the sheathing funnel 204 may be atranslational member that is axially displaceable relative to thetubular member 104 of the delivery device 100. The translational membermay be configured to translate axial movement of the translationalmember in a distal direction along the tubular member 104 into radialforce to compress and thereby crimp the unsheathed portion of the stent10. For example, the sheathing funnel 204 may interact with thesheathing fingers 206 during the sheathing action. The internal taper ofthe sheathing funnel 204 may interact with a ramped surface of thesheathing fingers 206. The angle of the sheathing fingers 206 combinedwith the internal taper of the sheathing funnel 204 may translate axialmovement of the sheathing tube 202 and sheathing funnel 204 into aradial force inward that may compress the stent 10 as the sheathing tube202 is advanced distally by the user. As the sheathing funnel 204 andsheathing tube 202 advances distally, the stent 10 is compressedgradually until the stent 10 is crimped and/or until an outer diameterof the stent 10 approximates the inner diameter of the stent pod 134. Acollar 205 may be disposed within the sheathing tube 202 and/orsheathing funnel 204 to engage the sheathing fingers 206 and therebyfacilitate sheathing. Sheathing of the stent 10 will be described ingreater detail below with reference to FIGS. 6A1-6A2, 6B1-6B2, 6C1-6C2,and 6D1-6D2.

FIG. 3 is an exploded view of the stent delivery system 100. FIGS.4A-4B, 4C and 4D1-4D2 are partially exploded, cut away, and/orcross-sectional side views of the stent delivery system 100. Referringcollectively to FIGS. 3 and 4A-4B, 4C and 4D1-4D2, the illustrated stentdelivery system 100 includes a handle 106, a rigid support tube 108,outer supports 110, a sheathing grip 112, a proximal trigger 114, adistal trigger 116, a floater 118, an internal connector 120, an innermember 122, a middle sheath 124, an outer sheath 126, a pusher/anchor(or panchor, as defined above) 128, and a tip 132. A pod 134 may bedisposed at, or configured to couple to, the distal end of the outersheath 126 to house a sheathed stent 10. A sheathing tube 202, asheathing funnel 204, sheathing fingers 206, and a tip insertion funnel208 facilitate sheathing of the stent 10 into the pod 134 and/or outersheath 126.

The trigger assembly 102, including the triggers 114, 116, the internalconnector 120, and the floater 118, facilitates deployment of the stent10 from a sheathed state within the pod 134. More specifically, thetrigger assembly 102 facilitates moving the outer sheath 126 proximallyrelative to the inner member 122, thereby retracting the pod 134 fromaround the stent 10 to expose and deploy the stent 10. Still morespecifically, the internal connector 120 may be bonded to the outersheath 126 and proximal movement of the internal connector 120 relativeto the handle 106 (and relative to the inner member 122 and outersupports 110) may cause proximal movement of the outer sheath 126relative to the inner member 122. Proximal movement of the outer sheath126 relative to the inner member 122 may result in deployment of thestent 10 sheathed within the pod 134. The triggers 114, 116 allow apractitioner to retract the outer sheath 126 proximally relative to theinner member 122 to deploy the stent, as will be explained in greaterdetail below with reference to FIGS. 8A1-8A2, 8B1-8B2, 8C1-8C2, and 8D.

The handle 106 is configured to be easily grasped by a practitioner tosecure and control the stent delivery device 101 (shown in FIG. 4A). Inthe illustrated embodiment, the handle 106 is shaped like the handle orbutt of a handgun and configured to position the triggers 114, 116similar to the position of a trigger of a handgun. The handle 106 may beergonomically configured to be comfortably gripped in a practitioner'shand.

The inner member 122 extends from the handle 106, through the triggerassembly 102, through the tubular member 104, to the panchor 128. Adistal inner segment 136 of the inner member 122 may be coupled to thetip 132 and configured for later coupling to the panchor 132 and/or theinner member 122 at the time of a stent implantation procedure. Thedistal inner segment 136 may be an elongate rigid shaft extending fromthe tip 132. The inner member 122 may be the inner-most component of thestent delivery device 101. The inner member 122, including the distalinner segment 136, may include a lumen and may be configured to receivea guidewire (not shown) that can guide insertion of the tubular member104 into a body lumen where the stent 10 is to be deployed. The innermember 122 may be formed of a flexible material, such as polyethylene,which can be easily manipulated over a guidewire into a body lumen. Inother embodiments, the inner member 122 may be formed of other flexiblematerials, including but not limited to nylon, Pebax, polypropylene, andTeflon. The distal segment may be formed of a slightly more rigidmaterial to facilitate insertion through a valve 12 of the stent 10and/or locking or coupling to the panchor 128 and/or the inner member122.

An inner assembly 140 (shown in FIG. 4B), which may include the rigidsupport tube 108, the middle sheath 124, and the panchor 128, may beconfigured around the inner member 122. The rigid support tube 108 maybe securely fixed to the handle 106 and may be configured to secure aproximal end of the inner member 122 relative to the handle 106. In theillustrated embodiment, the rigid support tube 108 may be formed of ametal, such as steel, and may be hollow and configured to receive theinner member 122. The steel rigid support tube 108 may then be crimpedat one or more points to secure the inner member 122 inside. In anotherembodiment the rigid support tube 108 may be formed of a rigid material,such as plastic, and secured to the inner member 122 by bonding, gluing,or other manner of affixing or securing the inner member 122 within orto the rigid support tube 108.

The tip 132 is configured to be positioned at the distal end of theouter sheath 126 and pod 134, when the stent delivery device 101 is in afully sheathed delivery configuration and the stent 10 is fullysheathed. In the illustrated embodiment, the distal inner segment 136 ofthe inner member 122 is coupled to the tip 132. The tip 132 may bebonded to or otherwise connected to the distal inner segment 136 of theinner member 122. The tip 132 may be formed of a molded plastic. Thedistal inner segment 136 may be an elongate shaft configured to extendthrough the lumen of the stent 10 to engage the panchor 128 and/orcouple to the inner member 122.

In the illustrated embodiment, the tip 132 and the distal inner segment136 are separated from the tubular member 104 of the stent deliverydevice 101 in the partially sheathed configuration (e.g., prior to useof the delivery system 100 by a practitioner). The distal inner segment136 is not typically positioned through a lumen of the stent 10 and thevalve 12 in the partially sheathed configuration so as to avoid plasticdeformation of the valve 12. The distal inner segment 136 may include aconnection member 138 configured to couple to the panchor 128. In oneembodiment, the connection member 138 may be a barb configured to matewith an opening within the panchor 128. The barb may include a taperedor ramped surface that allows the barb to pass through an opening withinthe panchor 128 in one direction and may include orthogonal surfacesthat inhibit passage of the barb through the opening within the panchor128 in an opposite direction. The opening within the panchor 128 mayinclude one or more deflectable tabs 129 configured to deflect (e.g.,spread apart) in response to contact with the tapered or ramped surfaceof the barb of the connection member 138. The deflectable tabs 129 mayretract to abut the orthogonal surface(s) of the barb and therebyrestrict passage of the barb back out of the opening within the panchor128.

A practitioner can insert the distal inner segment 136 through the lumenof the stent 10, including the valve 12, and engage the connectionmember 138 into the panchor 128 just prior to sheathing. The connectionmember 138 may be configured such that once the connection member 138 ofthe distal inner segment 136 is inserted into the panchor 128 the distalinner segment 136 cannot be removed. In this manner, the tip 132 issecured into position for sheathing and for the fully sheathed deliveryconfiguration.

The tip 132 may include a narrow lumen 133 that connects to a lumenthrough the distal inner segment 136 and the lumen of the inner member122 to allow a guidewire to be inserted into and through the innermember 122. The tip 132 may be formed in a conical shape, taperingtoward the distal end, to lead and guide the tubular member 104 duringinsertion into a lumen of the patient's body, for example, theesophagus. The connection member 138 of the distal inner segment 136 maycouple the distal segment to the panchor 128 in such a way that thelumen through the distal inner segment 136 and the tip 132 aligns withthe lumen of the inner member 122.

In some embodiments, one or more spacers 121 a, 121 b, 121 c(collectively 121) may be positioned around the distal inner segment 136of the inner member 122 and may extend proximally from the tip 132 tothe panchor 128. The spacers 121 may be free floating around (e.g.,coaxially with) the distal inner segment 136. The spacers 121 mayprovide a surface or other support structure against which the panchor128 (or segments of the panchor 128) may abut to restrict proximaland/or distal movement of the panchor 128 and panchor segment relativeto, for example, the tip 132. During sheathing of a stent, for example,forces may be exerted on the stent in a distal direction, which in turncreates forces in a distal direction on the panchor 128 and theindividual segments of the panchor 128. The distal forces on the panchor128 may cause the panchor segments to tend to separate. The one or morespacers 121 may restrict and/or prevent separation of panchor segmentsdue to distal forces on the panchor 128 created during sheathing.

In one embodiment, a first spacer 121 a may abut with and/or engage thepanchor 128. The first spacer 121 a may have an outer diameter sized toallow the first spacer 121 a to abut and/or engage an inner surface ofthe panchor 128. The second spacer 121 b may abut a distal end of thefirst spacer 121 a and have an outer diameter that is larger than theouter diameter of the first spacer 121 a. The larger diameter of thesecond spacer 121 b may enable the second spacer to engage the panchor128 and restrict distal movement of the panchor 128. More specifically,the second spacer 121 b may have an outer diameter large enough toengage an inner surface of a socket portion of the panchor 128 andthereby prevent a corresponding segment of the panchor 128 from movingdistally, for example relative to the tip 132. The third spacer 121 cmay abut a distal end of the second spacer 121 b and extend distally toabut the tip 132 and/or an outer tube portion of the distal innersegment 136. The third spacer 121 c may have an outer diameter similarto the diameter of the first spacer 121 a. The spacers 121 may be formedof a rigid material, such as a high yield strength polypropylene, toprovide a desired longitudinal rigidity to counteract the forces in thedistal direction exerted on the panchor 128 and/or panchor segments.

The pod 134 may house the stent 10 in a crimped configuration orotherwise compressed configuration. In other words, the stent 10 in acrimped configuration can be sheathed within the pod 134. The pod 134may be formed of a plurality of sheath layers (collectively 131) thatmay be reflowed to form a solid wall of material. Forming the pod 134from a plurality of sheath layers that are reflowed allows a way to bondthe pod 134 to a transition 135 and maintain constant an outsidediameter at a junction between the pod 134 and the transition 135. FIG.4D1 provides a side cross-sectional view of a portion of the pod 134,the transition 135, and the outer sheath 126. FIG. 4D2 provides anenlarged cross-sectional view of the same. In the embodiment shown inFIGS. 4D1 and 4D2, the pod 134 may comprise three sheath layers 131 a,131 b, 131 c, an outer sheath layer 131 a, a mid jacket sheath layer 131b, and a liner sheath layer 131 c. These sheath layers 131 may form awall of the pod 134. The liner sheath layer 131 c may be a 0.005″polytetrafluoroethylene (PTFE) liner, configured to limit frictionalforces between a sheathed stent and an inner surface of the pod 134. Themid jacket sheath layer 131 b may be 0.005″ 55D Pebax and may providestructural reinforcement to the wall of the pod 134. The outer sheathlayer may be 0.010″ 55D Pebax. The three layers can be reflowed withheat to fuse or meld them together and make them one solid wall ofmaterial.

The transition 135 may be molded, for example of Pebax, to taper from anouter diameter approximately equal to the outer diameter of the pod 134to an outer diameter approximately equal to the outer diameter of theouter sheath 126. The outer sheath layer 131 a may slide over a larger,distal end of the transition 135 while the mid jacket layer 131 b mayabut against the distal end of the transition 135. When reflowed, theouter sheath layer 131 a, a mid jacket sheath layer 131 b, and a linersheath layer 131 c may fuse or meld together and also fuse or meld tothe transition 135 and may form a single integral wall of the pod 134.

The panchor 128 is configured to secure the stent 10 within the pod 134.The panchor 128 may function as both a pusher and an anchor to restrictmovement of the stent both proximally and distally relative to thepanchor 128. More specifically, the panchor is configured to pushagainst the stent 10 as a force in a proximal direction is exerted onthe stent and configured to anchor the stent 10 as a force in a distaldirection is exerted on the stent 10. The panchor 128 may include one ormore annular flanges about an outer circumference of the panchor 128.The one or more annular flanges may engage the inner surface of thestent at one or more positions longitudinally along the stent 10. In oneembodiment, the one or more annular flanges may have five sides, suchthat an apex between each of the sides is configured to engage an innersurface of the stent 10 between connectors of the scaffolding structureof the stent 10. The panchor 128 is shown in FIGS. 14A-14H, and will bedescribed in greater detail below with reference to the same.

The middle sheath 124 is positioned around the inner member 122 inabutment with the rigid support tube 108 and the panchor 128. The middlesheath 124 may function as a space-filler between the inner member 122and the outer sheath 126. By filling the space between the inner member122 and the outer sheath 126, the middle sheath 124 can provideadditional structural support for the inner member 122 against buckling,crimping, and other undesired bending and/or collapse of the innermember 122 and/or the outer sheath 126. In particular, pressure on theinner member 122 created by forces in the longitudinal direction of theinner member 122 during deployment of a stent can cause the inner member122 to buckle, crimp, or otherwise bend in an undesirable fashion. Themiddle sheath 124 and the outer sheath 126 (in abutment with the middlesheath 124) provide additional structural support against buckling,crimping or other undesired bending of the inner member 122.

The inner assembly 140 (shown in FIG. 4B) may remain substantially fixed(in the proximal and distal directions) relative to the handle 106. Theouter sheath 126 is retracted proximally over the inner assembly 140 toexpose the distal region of the inner assembly 140. The trigger assembly102 may facilitate proximal retraction of the outer sheath 126.

The outer sheath 126 may substantially encase the inner assembly 140, orat least a distal region of the inner assembly 140. In the illustratedembodiment, when the stent delivery device 101 is in the fully sheatheddelivery configuration, the outer sheath 126 may abut a distal portionof the tip 132 and extend proximally toward a proximal end of the middlesheath 124, where the outer sheath 126 may couple to the internalconnector 120. As can be appreciated, in other embodiments the outersheath 126 may extend proximally to a greater or lesser degree as afunction of the positioning of, and/or coupling to, the internalconnector 120 and/or the distal trigger 116. The outer sheath 126 may beformed of a flexible material, such as nylon, which can be manipulatedinto a body lumen of a patient. In other embodiments, the outer sheath126 may be formed of other flexible materials, including but not limitedto polyethylene, Pebax, polypropylene, and Teflon.

The outer sheath 126 may couple to the smaller, proximal end of thetransition 135, as shown in FIGS. 4D1 and 4D2. The outer sheath 126 maybe formed of, for example, two layers 127 a, 127 b of Pebax and may beconfigured to couple to the proximal end of the transition 135 similarto the coupling of the pod 134 to the distal end of the transition 135.An outer layer 127 a may fit over the outer diameter of the proximal endof the transition 135 while an inner layer 127 b may abut against theproximal end of the transition 135. The two layers may be reflowed andfused or melded together and to the transition 135.

The outer supports 110 may support and/or provide a housing for thetrigger assembly 102. The outer supports 110 may include a plurality ofelongate shafts secured to and/or extending from the handle 106. Theouter supports 110 may be configured to provide a guide for a pluralityof triggers 114, 116, a housing for the trigger assembly 102, and astructure against which the trigger safety 142 can secure the triggers114, 116. In the illustrated embodiment, the outer supports 110 includean upper outer support 110 a and a lower outer support 110 b(collectively 110), each configured in a half cylindrical shape. Theouter supports 110 may mate together to form a housing around a portionof the proximal end of the outer sheath 126, the internal connector 120,the floater 118, and a proximal portion of the inner assembly 140.

The outer supports 110 also provide a support structure for the triggers114, 116. The triggers 114, 116 may be mounted on and/or positionedaround the outside of the outer supports 110 and are slidably movable,proximally and/or distally relative to the outer supports 110. The outersupports 110 also may be configured to form or otherwise provide one ormore trigger guide slots 150 (shown in FIG. 4A) to restrict rotationalmovement of the triggers about a longitudinal axis of the outer supports110. The trigger guide slots 150 also provide a track or guide for thetriggers 114, 116 as they move proximally and/or distally relative tothe outer supports 110. A proximal end of the outer supports 110 maycouple to the handle 106 and a distal end of the outer supports maycouple to the sheathing grip 112. The outer supports 110 may alsoprovide one or more trigger safety notches 144 configured to be engagedby the trigger safety 142 to limit proximal movement of the distaltrigger 116. In the illustrated embodiment, the trigger safety notches144 are adjacent to the trigger guide slots 150. In another embodiment,one or more trigger safety notches may be positioned separate from thetrigger guide slots 150.

The sheathing grip 112 may couple to the outer supports 110 and mayslidably abut against the outer sheath 126. The sheathing grip 112 maybe molded of soft Pebax to provide flexibility. The sheathing grip 112may be configured to relieve strain on the outer sheath 126 as thetubular member 104 is manipulated during insertion into a patient'sbody. Specifically, the sheathing grip 112 may be configured to allowthe outer sheath 126 to be displaced at an angle to the outer supports110 without kinking the outer sheath 126. This translates to allowingthe user to position, for example, a distal portion of the outer sheath126 at an angle to a main axis of the handle 106 and triggers 114, 116without kinking the outer sheath 126. If the outer sheath 126 is kinked,then the stent may not deploy. The strain relief component guardsagainst kinking of the outer sheath. The sheathing grip 112 may alsoallow the outer sheath 126 to slidably move longitudinally for sheathingand deployment of the stent.

The internal connector 120 may couple the outer sheath 126 and thedistal trigger 116. The internal connector 120 may be a rigid elongatetubular structure. In the illustrated embodiment, one or moreprotrusions 152 on the internal connector 120 near the proximal endextend radially outward to engage the distal trigger 116. The internalconnector 120 may be positioned within the housing formed by the outersupports 110. A distal portion of the internal connector 120 may bebonded to or otherwise coupled to the outer sheath 126. Accordingly,proximal movement of the internal connector 120 causes proximal movementof the outer sheath 126 relative to the inner member 122. Proximalmovement of the outer sheath 126 relative to the inner member 122results in deployment of a stent 10 sheathed within the pod 134.Similarly, distal movement of the outer sheath 126 relative to the innermember 122 causes distal movement of the internal connector 120. In oneembodiment the internal connector 120 may be partially inserted into alumen of the outer sheath 126, such that an outer surface of theinternal connector 120 is bonded to an interior surface of the outersheath 126. In another embodiment, the outer sheath 126 may be receivedinto the lumen of the internal connector 120, such that an interiorsurface of the internal connector 120 is bonded to an outer surface ofthe outer sheath 126. In still another embodiment, a distal edge of theinternal connector 120 may be bonded to a proximal edge of the outersheath 126. In still other embodiments, a coupling mechanism, such asbarbs, a pin, or the like may couple the internal connector 120 to theouter sheath 126.

The internal connector 120 may further include a floater engagementsurface 153 configured to be engaged by the floater 118 as it movesproximally relative to the internal connector 120. In the illustratedembodiment, the floater engagement surface may be at a proximal end of afloater engagement channel 160 in the internal connector 120. Theinternal connector 120 may include a pair of floater engagement channels160 configured to receive and guide a pair of barbed prongs 176 of thefloater 118. As the barbed prongs 176 move proximally within the floaterengagement channels 160, the barbs 178 may engage the floater engagementsurface 153. Accordingly, proximal movement of the floater 118 past agiven distance may result in proximal movement of the internal connector120. The given distance past which proximal movement of the floater 118results in proximal movement of the internal connector 120 may be thelength of the floater engagement channel 160. As can be appreciated, inanother embodiment the floater engagement surface 153 may also bepositioned on the distal trigger 116.

The distal trigger 116 may include a ring-shaped base with a pair offinger holds extending radially outward from the outer surface of thebase directly opposite one another. The distal trigger 116 is configuredto engage or otherwise couple to the internal connector 120. Theproximal trigger 114 may be configured similar to the distal trigger116, having a ring-shaped base and a pair of finger holds extendingradially outward from the outer surface of the base directly oppositeone another. The proximal trigger 114 is configured to engage orotherwise couple to the floater 118. The proximal trigger 114 and distaltrigger 116 are shown in FIGS. 10A and 10B, respectively, and describedin greater detail below with reference to the same.

The floater 118 may comprise a tubular shaft having a distal engagementmechanism 172 and a proximal engagement mechanism 174. In theillustrated embodiment, the distal engagement mechanism 172 may be oneor more barbed prongs 176 at the distal end of the floater 118. Thebarbed prongs 176 may include outwardly protruding barbs 178. The barbs178 may be configured to engage the distal trigger 116 and/or theproximal end of the internal connector 120 as the floater 118 isretracted proximally. For example, proximal movement of the floater 118past a given distance may result in the barbs 178 engaging the floaterengagement surface 153 of the internal connector 120 and in turn mayresult in proximal movement of the internal connector 120. The givendistance may be approximately the length of the floater engagementchannel 160 of the internal connector 120.

The barbs 178 may also be configured to allow the floater 118 to movedistally and to telescope into the internal connector 120. For example,the barbs 178 may be configured to slide distally for the length of thefloater engagement channel 160. The given distance may also beapproximately equivalent to the length of the floater 118, such that thedistal trigger 116 and internal connector 120 can be moved proximallyrelative to the floater 118 and proximal trigger 114 a length of thefloater 118 until the distal trigger 116 is drawn into abutment with theproximal trigger 114. This enables serial retraction of the distaltrigger 116 following retraction of the proximal trigger 114.

Stated differently, the distal engagement mechanism 172 may allow thefloater to move distally relative to the distal trigger 116 and theinternal connector 120 (and telescope into the internal connector 120).The distal engagement mechanism 172 may also limit proximal movement ofthe floater relative to the distal trigger 116 and the internalconnector 120 because the barbs 178 of the distal engagement mechanism172 engage the internal connector 120 (at the proximal end) and/orengage the distal trigger 116. Described still another way, the distalengagement mechanism 172 may allow the distal trigger 116 and theinternal connector 120 to move proximally relative to the floater 118(and proximal trigger), such that the distal trigger 116 can beretracted proximally toward the proximal trigger 114 to enable serialretraction of the proximal trigger 114 and distal trigger 116. Serialretraction of the triggers 114, 116 will be described in greater detailbelow with reference to FIGS. 8A1-8A2, 8B1-8B2, and 8C1-8C2.

In the illustrated embodiment, the proximal engagement mechanism 174 mayinclude a flange or lip around the circumference of the floater 118 atthe proximal end. The proximal engagement mechanism 174 may beconfigured to engage a floater engagement ring 170 (shown in FIG. 10A)of the proximal trigger 114, such that proximal movement of the proximaltrigger 114 results in proximal movement of the floater 118.Accordingly, proximal movement of the proximal trigger 114 relative tothe handle 106 and inner member 122 may result in proximal movement ofthe floater 118, the distal trigger 116, the internal connector 120, andthe outer sheath 126, thereby at least partially deploying the stent 10.Deployment of the stent 10 is described in greater detail below withreference to FIGS. 8A1-8A2, 8B1-8B2, 8C1-8C2, and 8D.

FIGS. 5A-5I are perspective views illustrating assembly of a sheathingmechanism 201 at a distal region of the stent delivery system 100 ofFIG. 1, sheathing of a stent 10, and disassembly of the sheathingmechanism 201, preparatory to performing a stent implantation procedure.The delivery device 100 begins in a partially sheathed configuration inFIG. 5A and ends in a fully sheathed delivery configuration in FIG. 5I.The components of the sheathing mechanism 201 are described referringcollectively to FIGS. 3 and 5A-5D.

FIG. 5A is a perspective view of the stent delivery system 100illustrating the sheathing tube 202 and sheathing funnel 204 disposedover the outer sheath 126 of the tubular member 104. The sheathing tube202 may have a tube-like cylindrical shape. The inner diameter of alumen of the sheathing tube 202 may be sized and shaped to be positionedover an outer diameter of a distal region of the outer sheath 126 and/orthe pod 134 of the delivery device 101. Furthermore, the sheathing tube202 lumen may have an inner diameter configured to allow the sheathingtube 202 to be slidably moveable relative to the outer sheath 126 and/orthe pod 134. In the illustrated embodiment, the sheathing tube 202 mayslide relative to the outer sheath 126 and relative to the pod 134without interference.

The sheathing funnel 204 may be disposed at a distal end of thesheathing tube 202. A proximal end of the sheathing funnel 204 may becoupled to the sheathing tube 202 in a manner that the inner diameter ofthe sheathing funnel 204 at the proximal end is approximately equivalentto the inner diameter of the sheathing tube 202 at the distal end. Thesheathing funnel 204 may have an internal taper configured to guide anexpanded portion of a stent 10 and the sheathing fingers 206 into thesheathing tube 202. Accordingly, the distal end of the sheathing funnel204 may have an inner diameter that is larger than the inner diameter ofthe proximal end of the sheathing funnel 204 and the inner diametertapers from the distal end to the proximal end.

The sheathing funnel 204 may include ribs 222 disposed on an internalsurface of the sheathing funnel 204 and extending in a directiongenerally from the distal end to the proximal end of the sheathingfunnel 204. The ribs of the sheathing funnel 204 are shown in greaterdetail in FIGS. 12A-12C and described in greater detail below withreference to the same. The ribs 222 may interact with the sheathingfingers 206 to cause the sheathing fingers 206 to align with the ribs222, such that a flared region 212 of the sheathing fingers ispositioned on either side of each rib 222 and the ribs are positioned inthe gaps between the flared regions 212. The ribs also interact with thestent 10 during sheathing. The sheathing funnel 204, and particularlythe ribs 222, guides the stent 10 and the sheathing fingers 206 into thesheathing tube 202 to crimp the stent 10 during (or substantiallycontemporaneous with) sheathing. The crimped stent 10 can then be drawninto and sheathed within the pod 134.

FIG. 5B illustrates the sheathing fingers 206 assembled and arrangedaround and/or in engagement with a distal region of the outer sheath 126(see e.g., FIG. 5A) and/or the pod 134. The flared portions 212 of thesheathing fingers 206 are disposed around the outer diameter of anunsheathed portion of the stent 10. The sheathing fingers 206, asmentioned, interact with the sheathing funnel 204 to aid in drawing thestent 10 into the sheathing tube 202 to crimp and sheath the stent inthe pod 134. In the illustrated embodiment, the sheathing mechanism 201includes a plurality of sheathing fingers 206 (e.g., two halves). Thesheathing fingers 206 may each include a base portion 214 and a flaredportion 212. The base portions 214 of the plurality of sheathing fingers206 may be configured to couple together to at least partially surrounda distal region of the outer sheath 126 and/or the pod 134. The baseportions 214, when coupled together around the outer sheath 126 may alsobe configured to be received into the sheathing tube 202, such that thebase portions 214 can be disposed between the outer sheath 126 (and/orthe pod 134) and the sheathing tube 202. FIG. 5B illustrates thesheathing tube 202 drawn up around a portion of the base portions 214 ofthe sheathing fingers 206.

In the illustrated embodiment, a proximal end of the base portions 214forms an inner taper configured to abut against a corresponding taperedregion at the transition between the outer sheath 126 and the pod 134.The inner taper of the base portions 214 may limit distal movement ofthe sheathing fingers 206 relative to the tubular member 104 of thestent delivery device 101, particularly during sheathing, which mayresult in pulling the pod 134 over the compressed stent 10.

The flared portions 212 (FIGS. 3 and 5A) may be configured to extenddistally beyond the distal end of the outer sheath 126 and extend alonga length of an unsheathed portion of the stent 10 beyond a distal end ofthe stent 10. The flared portions 214 may be arranged circumferentiallyabout an outer diameter of the unsheathed portion of the stent 10. Theflared portions 212 may be configured to collapse axially inward, towarda longitudinal axis of the stent 10 extending through the center of thelumen of the stent 10, as the flared portions 212 of the sheathingfingers 206 are drawn into the sheathing funnel 204 and/or sheathingtube 202 during a sheathing action. As the flared portions 212 collapseinwardly, they compress the stent 10 to an outer diameter less than theinner diameter of the pod 134. The pod 134 can then be drawn over thecompressed stent 10 to a fully sheathed delivery configuration.

In the illustrated embodiment, the flared portions 212 are divided intotwo elongate projections 216 forming a gap 217 in between theprojections 216. As described, ribs 222 on an inner surface of thesheathing funnel 204 may align with the gaps 217 between the projections216 to guide the flared portions 212 as they are drawn into thesheathing funnel 204. The gaps 217 may allow the flared portions 212 tocollapse and narrow (e.g., reduce the outer diameter) as the projections216 are drawn into and received into the sheathing funnel 204 andsheathing tube 202. The distal end of each projection 216 may include aflange 218 configured to couple to or otherwise receive the tipinsertion funnel 208.

FIG. 5C illustrates the tip insertion funnel 208 coupled to the distalends of the sheathing fingers 206. In particular, the tip insertionfunnel 208 may be configured to couple to the flanges 218 (see e.g.,FIG. 5B) at the distal ends of the elongate projections 216 of theflared portions 212 of the sheathing fingers 206. The tip insertionfunnel 208 tapers from a large distal opening 260 to a relatively smallproximal opening. The tapered shape of the tip insertion funnel 208 aidsto guide insertion of the distal inner segment 136 of the inner member122 as the distal inner segment 136 is inserted through the valve 12 ofthe stent 10 and into the panchor 128. As described above, the valve 12may be formed of an easily deformed polymer. The tip insertion funnel208 precisely guides the proximal end of the distal inner segment 136retrograde through the valve 12 to avert undesired contact and/ordamage, for example, to leaflets of the valve 12 or other portion of thevalve 12, as a result of imprecise insertion of the distal inner segment136. The connection member 138 at the proximal end of the distal innersegment 136 may be relatively sharp and/or pointed. As can beappreciated, even a relatively small force focused on the relativelynarrow point of the connection member 138 can multiply the force andcause damage to the valve 12 and/or plastically deform the valve 12. Thetip insertion funnel 208 provides a precise guide to properly insert thedistal inner segment 136 through the valve 12 without causing damage ordeformation. The stent delivery system 100 is in a partially sheathedconfiguration for storage and/or transport. With the aid of the tipinsertion funnel 208, the tip 132 and distal inner segment 136 canreadily be inserted by a practitioner. The tip insertion funnel 208 isshown in greater detail in FIGS. 15A-15C and is described below withreference to the same.

FIG. 5D illustrates the stent delivery system 100 in a partiallysheathed configuration with the tip 132 and distal inner segment 136inserted. The connection member 138 at the proximal end of the distalinner segment 136 is inserted through the tip insertion funnel 208,through the stent 10, including the valve 12, and into the panchor 128(not visible in FIG. 5D, but see FIG. 3). The sheathing mechanism 201 ofthe stent delivery system 100 is fully assembled at a distal region ofthe stent delivery device 101. The trigger safety 142 is positioned toprevent premature full deployment of the partially sheathed stent 10before the sheathing process that will fully sheathe the stent. Thetrigger safety 142 is positioned in engagement with the first triggersafety notch 144 a (hidden from view in FIG. 5D, but viewable in FIG. 3and FIG. 4A). During sheathing of the stent, the trigger safety 142 willtransition to the second trigger safety notch 144 b. The tip insertionfunnel 208 can be detached from the sheathing fingers 206 prior tosheathing.

FIG. 5E1 illustrates the tip insertion funnel 208 removed from thedistal ends of the sheathing fingers 206, preparatory to sheathing. Thetip insertion funnel 208 may be detached from the flanges 218 and/or thesheathing fingers 206 and opened to slide over the inserted tip 132.

FIG. 5E2 illustrates an end view of the distal end of the stent deliverysystem 100 with the sheathing mechanism 201 positioned as in FIG. 5E1.The flared portions 212 of the sheathing fingers 206 are in a flaredstate and the flanges 218 at a distal end of the elongate projections216 are extended outward beyond an outer perimeter of the sheathingfunnel 204. Other components are shown on the drawing for reference.

FIG. 5F1 illustrates the beginning of a sheathing action. A user, suchas a medical practitioner, may grasp in one hand the sheathing tube 202and/or sheathing funnel 204 of the assembled sheathing mechanism 201 andgrasp in the other hand the sheathing grip 112 of the stent deliverydevice 101. The user may push the sheathing tube 202 of the sheathingmechanism 201 forward toward the distal end of the stent delivery system100. In other words, the user may push or otherwise move (displace) thesheathing tube 202 and sheathing funnel 204 in a distal direction withthe first hand and away from the second hand and the sheathing grip 112,while restraining distal movement of the sheathing grip 112.

Alternatively and/or in addition, the practitioner can pull thesheathing grip 112 back in a proximal direction toward the handle 106 atthe proximal end of the stent delivery system 100. The sheathing funnel204 and/or the sheathing tube 202 and/or the sheathing fingers 206 pullthe pod 134 over the crimped stent 10. The pod 134 in turn pulls andmoves the outer sheath 126, the internal connector 120 (not visible inFIG. 5F1), the trigger safety 142, the distal trigger 116, the floater118 (not visible in FIG. 5F1), and the proximal trigger 114, all in adistal direction relative to the handle 106 and the tip 132. Thedisplacement also occurs relative to the components of the internalassembly, although the components of the internal assembly are notviewable, including the middle sheath 124, the panchor 128, the innermember 122, and the distal inner segment 136. Arrows indicate thedirection of the resulting movement relative to the handle 106. FIG. 5F1illustrates the sheathing tube 202 and sheathing funnel 204 movedslightly relative to FIG. 5E1. The sheathing funnel 204 is drawn overthe flared portions of the sheathing fingers, including the flanges 218.FIG. 5F1 also illustrates a displacement of the trigger safety 142, thedistal trigger 116 and the proximal trigger 114.

FIG. 5F2 illustrates an end view of the distal end of the stent deliverysystem 100 with the sheathing mechanism 201 positioned as in FIG. 5F1.The flanges 218 at a distal end of the elongate projections of theflared portions of the sheathing finger are drawn into and within anouter perimeter of the sheathing funnel 204. Other components are shownon the drawing of FIG. 5F2 for reference.

FIG. 5F3 is an enlarged sectional view of the sheathing funnel 204and/or the sheathing tube 202 with the flanges 218 disposed within thesheathing funnel 204. Further distal movement of the sheathing tube 202and/or sheathing funnel 204 cause the flanges 218 to engage against thecollar 205 disposed within the sheathing funnel 204 and/or the sheathingtube 202.

FIG. 5G1 illustrates another phase of the sheathing action. Thesheathing tube 202 and/or sheathing funnel 204 are moved distally overthe pod 134, the stent 10, the tip 132, and the flared portions 216 ofthe sheathing fingers 206 (not shown in FIG. 5G1 for clarity). Relativedisplacement of the sheathing tube 202 and/or sheathing funnel 204 canbe seen in comparison to FIG. 5F1. Pushing the sheathing tube 202 and/orsheathing funnel 204 may cause movement of the sheathing tube 202 and/orsheathing funnel 204 over the stent 10 and sheathing fingers 206 tocrimp the stent 10 and/or collapse the sheathing fingers 206 inwardly.In addition, movement of the sheathing tube 202 and/or sheathing funnel204 over the stent 10 and sheathing fingers 206 may pull the outersheath 126 over the crimped stent 10. The flanges 218 of the sheathingfingers 206 may engage the collar 205 within the inner surface of thetapered sheathing funnel 204 and/or the sheathing tube 202. Theengagement of the flanges 218 with the collar 205 may cause the distalmovement of the sheathing funnel 204 and/or the sheathing tube 202 tomove the sheathing fingers 206, which in turn move the outer sheath 126distally to sheath the crimped stent 10.

Again, movement of the outer sheath 126 relative to the handle may inturn result in displacement of the internal connector 120 (not visiblein FIG. 5G1), the trigger safety 142, the distal trigger 116, thefloater 118 (not visible in FIG. 5G1), and the proximal trigger 114, allin a distal direction relative to the handle 106 and the tip 132. Arrowsindicate the direction of the resulting movement relative to the handle106.

The distal movement of the sheathing tube 202 and sheathing funnel 204collapses the sheathing fingers 206, which crimps or compresses thestent 10 to a diameter smaller than the inner diameter of the pod 134.The distal movement of the sheathing tube 202 and sheathing funnel 204also pulls the pod 134 over the compressed stent 10 to fully sheathe thestent 10. When the trigger safety 142 reaches a second trigger safetynotch 144 b (FIGS. 5E1 and 5F1), it may make an audible click toindicate that the stent 10 is fully sheathed and the stent deliverysystem 100 is in the fully sheathed delivery configuration. In FIG. 5G1,the outer sheath 126, the trigger safety 142, the distal trigger 116,and the proximal trigger 114 are all shifted distally relative to thehandle 106. The trigger safety 142 is positioned to engage the secondtrigger safety notch 144 b. Although not visible in the view of FIG.5G1, the internal connector 120 and the floater 118 are also shifteddistally.

FIG. 5G2 illustrates an end view of the distal end of the stent deliverysystem 100 with the sheathing mechanism 201 positioned as in FIG. 5G1.The flanges 218 at a distal end of the elongate projections of theflared portions of the sheathing finger are more fully drawn into thesheathing funnel 204 and are entirely collapsed inward and abutting eachother. The flanges 218 may be engaging the collar 205 disposed withinthe sheathing funnel 204 and/or the sheathing tube 202.

FIG. 5G3 is an enlarged sectional view of the sheathing funnel 204and/or the sheathing tube 202 with the flanges 218 engaged against thecollar 205 disposed within the sheathing funnel 204 and/or the sheathingtube 202. The collar 205 causes distal movement of the sheathing funnel204 and/or the sheathing tube 202 to distally displace the sheathingfingers 206, thereby distally moving the outer sheath 126 to sheathe thecrimped stent 10.

FIGS. 5H and 5I illustrate disassembly of the components of thesheathing mechanism 201 (see FIG. 2), preparatory to an implantationprocedure to implant the stent 10. In FIG. 5H, the sheathing tube 202and/or sheathing funnel 204 are shown retracted proximally to expose thesheathing fingers 206 and/or the pod 134, such that the sheathingfingers 206 can be removed. The sheathing fingers 206 are shownseparated and detached from around the pod 134. The pod 134 is slid overan entire length of the stent 10, thereby sheathing the stent.

FIG. 5I illustrates the sheathing tube 202 and sheathing funnel 204pulled over the pod 134 and tip 132 and removed from the tubular member104 of the stent delivery device 101. The stent delivery device 101 isnow in a fully sheathed delivery configuration and ready for use in aprocedure to deploy the stent 10 in a target lumen of a patient needingtreatment.

FIGS. 6A1-6A2, 6B1-6B2, 6C1-6C2, and 6D1-6D2 are cross-sectional viewsof the stent delivery system of FIG. 1, at various positions duringsheathing of a partially sheathed stent 10 to transition the stentdelivery system 100 from a partially sheathed configuration to a fullysheathed delivery configuration.

FIG. 6A1 is a side view of the stent delivery system 100 in a partiallysheathed configuration and a similar configuration as in FIG. 5E1. FIG.6A2 is an enlarged cross-sectional side view of a distal region of thestent delivery system 100. Referring generally and collectively to FIGS.6A1 and 6A2, the stent delivery system 100 is prepared for the sheathingprocess. The tip 132 and distal inner segment 136 are inserted into thepanchor 128 and the stent 10 is partially sheathed within the pod 134.The pod 134 is at position P_(s)pod₁ and partially enclosing a crimpedor compressed portion of the stent 10. In other words, the stent 10 ispartially sheathed. The valve 12 is in an uncompressed, uncrimped, andunsheathed portion of the stent 10, such that the valve is in a natural(e.g., undeformed) operable configuration and not subject to forces thatmay induce plastic deformation. The trigger safety 142 is engaged aroundthe outer supports 110 at a first trigger safety notch 144 a (notvisible in FIG. 6A1, but see FIG. 6B1) at position P_(s)t₁. A secondtrigger safety notch 144 b is visible. The distal trigger 116 ispositioned adjacent the trigger safety 142 at position P_(s)d₁. Theproximal trigger 114 is positioned at position P_(s)p₁ substantially inabutment with the handle 106 and at or toward a proximal end of the oneor more trigger guide slots 150 of the outer supports 110.

FIG. 6B1 is a side view of the stent delivery system 100 partiallythrough the sheathing process and in a similar position as in FIG. 5F1.FIG. 6B2 is an enlarged cross-sectional side view of the distal regionof the stent delivery system 100 showing the stent 10 being drawn intoand sheathed within the pod 134. Referring generally and collectively toFIGS. 6B1 and 6B2, as the sheathing tube 202 and the sheathing funnel204 are moved distally relative to the handle 106, the outer sheath 126,the trigger safety 142, the distal trigger 116, and the proximal trigger114 also move distally relative to the handle 106. The pod 134 may beslightly displaced from position P_(s)pod₁ and is now at positionP_(s)pod₂. The displacement may be due to frictional forces (asdepicted) or may be due to the flanges 218 engaging and being moved bythe sheathing funnel 204 and/or the sheathing tube 202. Also, thetrigger safety 142 is displaced from position P_(s)t₁ to positionP_(s)t₂, distally toward the second trigger safety notch 144 b.Similarly, the distal trigger 116 is displaced distally from positionP_(s)d₁ to position P_(s)d₂ and the proximal trigger 114 is displacedfrom position P_(s)p₁ to position P_(s)p₂. Although not visible in FIG.6B1, the internal connector 120 and the floater 118 also move distally.More particularly, the sheathing tube 202 and sheathing funnel 204 arepushed distally, in turn pulling the pod 134 from position P_(s)pod₁ toposition P_(s)pod₂, the outer sheath 126 the internal connector 120, thetrigger safety 142 from position P_(s)d₁ to position P_(s)t₂, the distaltrigger 116 from position P_(s)d₁ to position P_(s)d₂, the floater 118and the proximal trigger 114 from position P_(s)p₁ to position P_(s)p₂.The movement of these components may continue until the trigger safety142 engages the second trigger safety notch 144 b. An audible click maybe made by the trigger safety 142 as it engages the second triggersafety notch 144 b. The first trigger safety notch 144 a is now visible.

FIG. 6C1 is a side view of the stent delivery system 100 at a completionof distal movement of the sheathing tube 202 and the sheathing funnel204 during the sheathing process and in a similar position as in FIG.5G1. FIG. 6C2 is an enlarged cross-sectional side view of the pod 134and the stent 10 sheathed within the pod 134. Referring generally andcollectively to FIGS. 6C1 and 6C2, the stent 10 is fully sheathed. Thepod 134 is now displaced from position P_(s)pod₂ to position P_(s)pod₃.Additional distal displacement of the sheathing tube 202 and/orsheathing funnel 204 resulted in abutment of the flanges 218 with thecollar 205 disposed within the sheathing tube 202 and/or sheathingfunnel 204. The collar 205 in turn transfers force in the longitudinaldirection to the flanges 218, resulting in longitudinal movement of thesheathing fingers 206 and movement of the pod 134 over the crimped stent10 from position P_(s)pod₂ to position P_(s)pod₃. The distal trigger 116and proximal trigger 114 are also shifted distally in preparation forretraction to deploy the stent 10. Specifically, the distal trigger 116is now shown displaced distally from position P_(s)d₂ to positionP_(s)d₃ and the proximal trigger 114 is displaced from position P_(s)p₂to position P_(s)p₃. Although not visible in FIG. 6C1, the internalconnector 120 and the floater 118 are also displaced distally. Thetrigger safety 142 is displaced from position P_(s)t₂ to positionP_(s)t₃ in engagement with the second trigger safety notch 144 b tolimit (e.g., prevent) inadvertent deployment of the stent 10. Theflanges 218 of the sheathing fingers 206 are also engaged with thecollar 205 that may be disposed within the sheathing funnel 204 and/orthe sheathing tube 202. Accordingly, further distal movement of thesheathing funnel 204 and/or the sheathing tube 202 may result in distalmovement of the sheathing fingers 206, which in turn results in distalmovement of the pod 134 and outer sheath 126.

FIG. 6D1 is a side view of the stent delivery system 100 in a fullysheathed delivery configuration similar to the configuration in FIG. 5I.FIG. 6D1 illustrates the sheathing tube 202, sheathing funnel 204 andthe sheathing fingers 206 removed after the sheathing process. FIG. 6D2is an enlarged cross-sectional side view of the distal region of thestent delivery system 100 with the stent 10 fully sheathed within thepod 134. Referring generally and collectively to FIGS. 6D1 and 6D2, theone or more spacers 121 a, 121 b, 121 c (collectively 121) can be seenpositioned around a portion of the distal inner segment 136. The spacers121 may be free floating around (e.g., coaxially with) a portion of thedistal inner segment 136. The spacers 121 may provide a surface or othersupport structure against which the panchor 128 (or segments of thepanchor 128) may abut to restrict proximal and/or distal movement of thepanchor 128, or segment thereof, relative to, for example, the tip 132.During sheathing of a stent, for example, forces may be exerted on thestent in a distal direction, which in turn may create forces in a distaldirection on the panchor 128, including individual segments of thepanchor 128. The distal forces on the panchor 128 may cause the segmentsof the panchor 128, for example, to tend to separate. The one or morespacers 121 may restrict and/or prevent separation of panchor segmentsdue to distal forces on the panchor 128 created during sheathing. Thesegments of a panchor 128 are shown in FIGS. 14B-14E and described belowwith reference to the same.

In one embodiment, a first spacer 121 a may abut with and/or engage thepanchor 128. The first spacer 121 a may have an outer diameter sized toallow the first spacer 121 a to abut and/or engage an inner surface ofthe panchor 128. The second spacer 121 b may abut a distal end of thefirst spacer 121 a and have an outer diameter that is larger than theouter diameter of the first spacer 121 a. The larger diameter of thesecond spacer 121 b may enable the second spacer to engage the panchor128 and restrict distal movement of the panchor 128, includingindividual segments of the panchor 128. More specifically, the secondspacer 121 b may have an outer diameter large enough to engage an innersurface of a socket portion of the panchor 128 and thereby limit distalmovement of a corresponding segment of the panchor 128, for examplerelative to the tip 132. The third spacer 121 c may abut a distal end ofthe second spacer 121 b and extend distally to abut the tip 132 and/oran outer tube portion 136 b of the distal inner segment 136. The distalinner segment 136 may comprise an outer tube portion 136 b and an innertube portion 136 a positioned coaxially within the outer tube portion136 b. The outer tube portion 136 b may extend a portion of the lengthof the distal inner segment 136 and provide a protruding surface (e.g.,protruding relative to the inner tube portion) against which the thirdspacer 121 a can abut. The inner tube portion 136 a may extend thelength of the distal inner segment 136 from the tip to the connectionmember 138. The outer tube portion 136 b may be bonded to the inner tubeportion 136 a.

FIG. 7A is a cross-sectional view of the stent delivery system 100 inthe fully sheathed delivery configuration preparatory to use in amedical procedure, prior to the trigger safety 142 being removed. Thetrigger safety 142 is engaged around the outer supports 110 at thesecond trigger safety notch 144 b. FIG. 7A portrays an interrelation ofvarious components of the stent delivery system 100, including but notlimited to the handle 106, the outer supports 110, the floater 118, thetriggers 114, 116, the trigger safety 142, the internal connector 120,the sheathing grip 112, the outer sheath 126, the middle sheath 124, theinner member 122, the panchor 128, the pod 134 and the tip 132. FIG. 7Bis a close-up cross-sectional view of the stent 10 in a compressedconfiguration within the pod 134. The panchor 128 may include an anchor198 configured to be positioned between connectors 18 of the stent 10that interconnect annular segments 14 (or rows of struts 16 or strutarms) in a scaffolding structure of the stent 10. The anchors 198 mayengage the distal ends of the struts 16 and thereby engage the stent 10to limit distal movement of the stent 10 relative to the panchor 128.For example, the anchors 198 may be arranged radially to be positionedcircumferentially between the connectors 18. The stent 10 is compressedaround the panchor 128 and/or the distal inner segment 136. The spacers121 a, 121 b, 121 c, may be disposed between the distal inner segment136 and the panchor 128 and/or the stent 10.

FIGS. 8A1-8A2, 8B1-8B2, 8C1-8C2, and 8D are side longitudinalcross-sectional views of the trigger assembly of the stent deliverysystem 100, at various positions during deployment of the stent 10.FIGS. 8A1-8A2, 8B1-8B2, 8C1-8C2, and 8D illustrate operation of theproximal trigger 114, the floater 118, the distal trigger 116, theinternal connector 120, and the outer sheath 126 to deploy a stent 10.

FIG. 8A1 shows the stent delivery system 100 with the trigger safety 142removed. The stent delivery system 100 may be ready to deploy the stent10. The pod 134 is abutting the tip 132 at position P_(d)pod₁,completely over and fully enclosing the collapsed stent 10. The distaltrigger 116 is positioned substantially at or toward the distal end ofthe one or more trigger guide slots 150 (see e.g., FIG. 2) of the outersupports 110 at position P_(d)d₁. The proximal trigger 114 is positionedat position P_(d)p₁. The trigger safety 142 is removed (and therefore isnot shown in FIGS. 8A1-8A2, 8B1-8B2, 8C1-8C2, and 8D), thereby allowingretraction of the triggers 114, 116 and deployment of the stent 10 tooccur. FIG. 8A2 is a close up view of the panchor 128 engaging thecompressed and fully sheathed stent 10 within the pod 134.

FIG. 8B1 is a side longitudinal cross-sectional view of the stentdelivery system 100 with the proximal trigger 114 retracted fromposition P_(d)p₁ to position P_(d)p₂. and the stent 10 partiallydeployed. Proximal retraction of the proximal trigger 114 results inproximal retraction of the floater 118, which in turn displaces thedistal trigger 116 from P_(d)d₁ to position P_(d)d₂. As shown, positionP_(d)d₂ may be substantially proximate to position P_(d)p₁. Proximalretraction of the distal trigger 116 may result in proximal retractionof the internal connector 120 and the outer sheath 126. Proximalretraction of the outer sheath 126 results in at least partialdeployment of the stent 10. The pod 134 is shown displaced proximallyfrom position P_(d)pod₁ to position P_(d)pod₂, away from the tip 132,exposing a portion of the stent 10. The stent 10, which is expanded inthe area exposed outside the pod 134, is partially deployed. When theproximal trigger 114 is fully retracted, a practitioner can more easilyreach the distal trigger 116. FIG. 8B2 is a close up view of thepartially deployed stent 10 partially compressed within the pod 134.

FIGS. 8C1 and 8C2 are side longitudinal cross-sectional views of thestent delivery system 100 with the distal trigger 116 fully retractedfrom position P_(d)d₁ to position P_(d)d₃. The floater 118 is telescopedinto the internal connector 120. The pod 134 is completely retracted,from position P_(d)pod₁ to position P_(d)pod₃, fully withdrawn from thestent 10 allowing the stent 10 to fully expand and deploy.

As described above, the design and coupling of the floater 118 to theinternal connector 120 (and/or distal trigger 116) allow the internalconnector 120 and distal trigger 116 to move proximally relative to thefloater 118 and the proximal trigger 114, thus enabling the two-triggermechanism of the stent delivery system 100. The two-trigger mechanismenables serial retraction of the triggers 114, 116. A two-trigger designallows an elegant, ergonomic mechanism to enable a practitioner todeploy a longer stent (e.g., a stent with a length longer than thefinger span of the practitioner). The two-trigger design also allows atwo-stage stent deployment process, enabling repositioning of the stentafter partial deployment and before complete deployment. A three-triggerdesign enables deployment of still longer stents, as described belowwith reference to FIGS. 16A, 16B, 17A, 17B, and 18A-18C. Typically, amaximum trigger reach of a hand of a woman over sixty years of age inthe fifth percentile is approximately 3.4 inches. Accordingly, thedistance between the triggers and/or handle may be no greater thanapproximately 3.4 inches. Accordingly, the distance between the triggersand/or handle may be less than approximately 3.4 inches.

FIG. 8D is a close-up view of the stent 10 in the fully expanded,deployed state within a lumen of the body. The tip 132 and distal innersegment 136 are shown as being partially withdrawn proximally (in thedirection of the arrows) through the valve 12 of the stent 10.

FIGS. 9A and 9B are a transverse cross-sectional view and a longitudinalcross-sectional view, respectively, of a portion of the stent deliverysystem 100. FIG. 9A provides a transverse cross-sectional view of thestent delivery system 100 through the trigger safety 142. FIG. 9Aillustrates the nested positioning of the trigger safety 142, the outersupports 110, the floater 118, the rigid support tube 108, and the innermember 122.

FIG. 9B provides a top longitudinal cross-sectional view of the stentdelivery system 100. FIG. 9B illustrates a number of componentrelationships, according to one embodiment. Looking from right to lefton the figure, the outer sheath 126 is received into and bonded to aninterior surface of the internal connector 120. The internal connector120 passes through and engages the distal trigger 116. Specifically, oneor more protrusions 152 (see e.g., FIG. 3) extending radially outwardfrom the internal connector 120 engage the distal trigger 116. As shownin FIG. 9B, a first pair of protrusions 152 a are configured to engageand/or abut a proximal end of the distal trigger 116 and a second pairof protrusions 152 b are configured to engage and/or abut a distal endof the distal trigger 116. The floater 118 couples together the proximaltrigger 114 and the internal connector 120 and distal trigger 116. Inthe illustrated embodiment, the distal engagement mechanism 172 (FIG. 3)of the floater 118 engages the internal connector 120 and the proximalengagement connector 174 engages the floater engagement ring 170 (FIG.10A) of the proximal trigger 114. The rigid support tube 108 extendswithin the floater 118 and the internal connector 120 and around theinner member 122.

The trigger safety 142 is wrapped around or otherwise engages the outersupports 110. Inward protrusions 188 of the trigger safety 142 engage atrigger safety notch 144 b formed by the outer supports 110 to limitproximal movement of the trigger safety 142 relative to the outersupports 110. Alignment ribs 189 protruding inward from an inner surfaceof the trigger safety 142 are received into the trigger guide slots 150(see e.g., FIG. 9A) and align the trigger safety 142. The alignment ribs189 may also engage a third pair of protrusions 152 c on the internalconnector 120 radiating outward. The engagement of the alignment ribs189 with the protrusions 152 c of the internal connector 120 limitsproximal movement of the internal connector 120 relative to the triggersafety 142 and the outer supports, thereby restricting deployment of thestent 10. The second pair of protrusions 152 b may also be configured toengage alignment ribs 189 of the trigger safety, such that distalmovement of the internal connector 120 may result in distal movement ofthe trigger safety 142, for example during sheathing of a stent.

FIGS. 10A and 10B are end views of the triggers 114, 116 of the stentdelivery system 100 of FIG. 1. FIG. 10A is an end view of the proximaltrigger 114 and FIG. 10B is an end view of the distal trigger 116.

Referring to FIG. 10A, the proximal trigger 114 may have a ring-shapedbase 164 and a pair of finger holds 166 extending radially outward fromthe outer surface of the base 164 directly opposite one another. One ormore trigger guides 168 may protrude radially inward from the base 164to engage the trigger guide slot 150 formed by the outer supports 110(FIGS. 2, 9A). The trigger guides 168 may restrict rotation of theproximal trigger 114 about the outer supports 110 while allowingproximal and distal movement of the proximal trigger 114. The proximaltrigger 114 may also include a floater engagement ring 170 to engage theproximal engagement mechanism 174 (FIG. 3) of the floater 118, such thatproximal movement of the proximal trigger 114 results in proximalmovement of the floater 118.

Referring to FIG. 10B, the distal trigger 116 may be configuredsimilarly to the proximal trigger 114, having a ring-shaped base 154with a pair of finger holds 156 extending radially outward from theouter surface of the base 154 directly opposite one another. One or moretrigger guides 158 may protrude radially inward from the base 154 toengage the trigger guide slot 150 formed by the outer supports 110(FIGS. 2, 9A, 9B). The trigger guides 158 may restrict rotation of thedistal trigger 116 about the outer supports 110 while allowing proximaland distal movement of the distal trigger 116. The distal trigger 116 isconfigured to engage or otherwise couple to the internal connector 120(FIGS. 3, 9A, 9B).

FIGS. 11A and 11B are a side view and a top cross-sectional view,respectively, of an internal connector 120, a distal trigger 116, afloater 118, and a proximal trigger 114 of the stent delivery system100. FIGS. 11A and 11B illustrate the coupling relationship of theinternal connector 120, the distal trigger 116, the floater 118, and theproximal trigger 114. Referring collectively to FIGS. 11A and 11B, thedistal trigger 116 couples to the internal connector 120. In theillustrated embodiment, the one or more outwardly extending protrusions152 on the internal connector 120 mate with the trigger guides 158. Asthe distal trigger 116 is retracted proximally, toward the handle 106,the distal trigger 116 retracts the internal connector 120 proximally.Thus, retraction of the distal trigger 116 results in retraction of theouter sheath 126 and pod 134 (FIGS. 2 and 3), which results in at leastpartial deployment of the stent 10.

The proximal trigger 114 is mechanically coupled to the distal trigger116 by the floater 118. In the illustrated embodiment, the proximaltrigger 114 further includes a floater engagement ring 170 coupled tothe inwardly protruding trigger guides 168 (see also FIG. 10A). Thefloater engagement ring 170 may engage the proximal engagement mechanism174 at the proximal end of the floater 118, such that proximal movementof the proximal trigger 114 in turn retracts the floater 118. The distalend of the floater in turn engages the distal trigger 116 and/or theinternal connector 120. Accordingly, retraction of the proximal trigger114 results in retraction of the distal trigger 116 and/or the internalconnector 120, which results in at least partial deployment of the stent10.

FIGS. 12A-12C are various views of the sheathing funnel 204 andsheathing tube 202 of the stent delivery system 100. FIG. 12A is aperspective view of the sheathing mechanism 201 disposed at the distalend of a stent delivery device 101 and showing positioning of thesheathing funnel 204 and sheathing tube 202 in the assembled sheathingmechanism 201. FIG. 12B is an end view of the sheathing funnel 204 andFIG. 12C is a perspective end view of the sheathing funnel 204.

Referring collectively to FIGS. 12A-12C, the sheathing tube 202 may havea tube-like cylindrical shape. The inner diameter d_(i) of a lumen ofthe sheathing tube 202 may be sized and shaped to be positioned over anouter diameter of a distal region of the outer sheath 126 and/or the pod134 of the delivery device 101. Furthermore, a lumen of the sheathingtube 202 may have an inner diameter configured to allow the sheathingtube 202 to be slidably moveable relative to the outer sheath 126 and/orthe pod 134. The sheathing tube 202 may slide relative to the outersheath 126 and relative to the pod 134 without interference. Thesheathing tube 202 may also slide relative to the sheathing fingers 206.

The sheathing funnel 204 may be disposed at a distal end of thesheathing tube 202. A proximal end of the sheathing funnel 204 may becoupled to the sheathing tube 202 in a manner that the inner diameter ofthe sheathing funnel 204 at the proximal end is approximately equivalentto the inner diameter d_(i) of the sheathing tube 202 at the distal end.The sheathing funnel 204 has an internal taper configured to guide anexpanded portion of a stent 10 and the sheathing fingers 206 into thesheathing tube 202. Accordingly, the distal end of the sheathing funnel204 may have an inner diameter that is larger than the inner diameterd_(i) of the proximal end of the sheathing funnel 204 and the innerdiameter of the sheathing funnel 204 may taper from the distal end tothe proximal end.

The sheathing funnel 204 may include ribs 222 disposed on an internalsurface of the sheathing funnel 204 and extending in a directiongenerally from the distal end to the proximal end of the sheathingfunnel 204. The ribs 222 may be configured to interact with thesheathing fingers 206 to cause the sheathing fingers 206 to align withthe ribs 222 such that an elongate projection 216 of a flared region 212of the sheathing fingers 206 is positioned on either side of each rib222 and the ribs 222 are positioned in the gaps between the flaredregions 212. The ribs 222 also interact with the stent 10 duringsheathing. The sheathing funnel 204, and particularly the ribs 222,guides the stent 10 and the sheathing fingers 206 into the sheathingtube 202 to crimp the stent 10 during sheathing. The crimped stent 10can then be sheathed or drawn into the pod 134.

The elongate projections 216 of the sheathing finger 206 may include oneor more rails 219 or similar thicker portion disposed on an outersurface and configured to contact the inner surface of the sheathingfunnel 204 and/or sheathing tube 202 during a sheathing process. Therails 219 may function to reduce frictional forces between theprojections 216 and the sheathing funnel 204 and/or sheathing tube 202during sheathing of a stent 10.

The sheathing funnel 204 and/or sheathing tube 202 may include and/ordefine an annular collar 205 on an interior surface of the sheathingfunnel 204 and/or sheathing tube 202. The collar 205 may be configuredto engage and cause distal movement of the flanges 218 (at a distal endof the elongate projections 216 of the flared portion 212 of thesheathing fingers 206) as the sheathing funnel 204 and/or sheathing tube202 is advanced distally over the sheathing fingers 206. Engagement ofthe collar 205 with the flanges 218 during distal movement of the collar205 may result in distal movement of the sheathing fingers 206,resulting in distal movement of the pod 134 to sheathe the crimpedportion of the stent 10.

FIGS. 13A-13C are a trigger safety 142 of the stent delivery system 100,according to one embodiment. FIG. 13A is a perspective view of thetrigger safety 142. FIG. 13B is a side view of the trigger safety 142 ina closed state. FIG. 13C is a side view of the trigger safety 142 in anopen state.

Referring collectively to FIGS. 13A-13C, the trigger safety 142 mayinclude an annular body 182 and a release tab 184. The annular body 182may be configured to, in a closed configuration, encircle and engage theouter supports 110 (shown in FIG. 9A). The release tab 184 releases theannular body 182 to open the annular body 182 to allow the annular body182 to transition to an open configuration and disengage from the outersupports 110 and thereby release the trigger safety 142. The annularbody 182 may further include various protrusions 188 and ribs 189 on aninner surface to engage or otherwise interact with the outer supports110.

The body 182 may have an annular shape configured to wrap around theouter supports 110 of the stent delivery device 101. The body 182 maycomprise a hinge 186 to allow the body 182 to open and disengage fromthe outer supports 110. One or more inward protrusions 188 may beconfigured to engage a trigger safety notch 144 a, 144 b (shown in FIGS.3, 5F1, 6B1, and 9B) of the outer supports 110.

The protrusions 188 may each extend inwardly from a deflectable tab 187formed in the body 182 and be designed and configured to allow distalmovement of the trigger safety 142 (for sheathing) while restrictingproximal movement of the trigger safety 142. Specifically, the triggersafety 142, when in an operable state and engaged with the first triggersafety notch 144 a (see e.g., FIG. 3), may be moved distally from thefirst trigger safety notch 144 a to the second trigger safety notch 144b (see e.g., FIG. 3). The deflectable tabs 187 may enable theprotrusions 188 to withdraw from engagement with the trigger safetynotches 144.

The protrusions 188 may have a ramped distal side configured to interactwith a distal edge of the first trigger safety notch 144 a as thetrigger safety 142 is moved distally. The proximal side of theprotrusions may be straight, or unramped, and configured to engage theproximal edge of the trigger safety notches 144 (see e.g., FIG. 3) andthereby restrict proximal movement of the trigger safety 142 relative tothe outer supports 110. The ramped distal side may act as a ramp tocause the protrusions 188 to be raised out of engagement with the firsttrigger safety notch 144 a in response to distal movement of the triggersafety 142 relative to the outer supports 110. The ramped distal sidemay interact with a distal edge of the trigger safety notches 144, whichurges the protrusion out of the trigger safety notch. As the protrusions188 rise out of engagement with first trigger safety notch 144 a, thedeflectable tabs 187 bend or deflect to a deflected state to accommodatethe outward shift of the protrusions 188.

The deflectable tabs 187 may be biased toward an undeflected state. Whenthe proximal side of the protrusions 188 reach the second trigger safetynotch 144 b, the deflectable tabs spring back to the undeflected statecausing the protrusions 188 to engage the second trigger safety notch144 b and restrict proximal movement of the trigger safety 142. Thespringing back of the deflectable tabs 187 and the protrusions 188 maycause an audible click to signal that the stent delivery system 100 hasreached the fully sheathed delivery configuration.

One or more alignment ribs 189 (or similar protrusions) disposed on theinner surface of the body 182 are configured to be received in thetrigger guide slot 150 (see e.g., FIG. 2) to appropriately align thetrigger safety 142. The ribs 189 are also configured to engage theprotrusions 152 on the internal connector 120 (FIGS. 3, 9A, 9B) andrestrict proximal movement of the internal connector 120 and distaltrigger 116 (see e.g., FIG. 2). When the internal connector 120 isunable to move proximally, the floater 118 (see e.g., FIGS. 3, 9B), theproximal trigger 114 (FIGS. 3, 9B) and the outer sheath 126 also cannotmove proximally. In this manner, the trigger safety 142 may guardagainst inadvertent or accidental deployment of a sheathed stent.

Described differently, the ribs 189 may be configured to restrictmovement of the internal connector 120 (and thus the outer sheath 126)relative to the trigger safety 142 when the annular body 182 is in theclosed configuration around the outer supports 110 of the stent deliverydevice 101. The protrusions 188 may be configured to engage the triggersafety notches 144 of the outer supports 110 of the stent deliverydevice 101 when the annular body is in the closed configuration andrestrict proximal movement of the trigger safety 142 relative to theouter supports 110 of the delivery device 101. The protrusions 188 incombination with the deflectable tabs 187 permit distal movement of thetrigger safety 142 relative to the outer supports 110 of the stentdelivery device 101 to allow distal movement of the outer sheath 126relative to the inner member 122 (and, among other things, the panchor128 and the stent 10) of the tubular member of the stent delivery device101. The distal movement of the trigger safety 142 relative to thehousing allows the transition of the stent delivery device 101 from thepartially sheathed configuration to the fully sheathed deliveryconfiguration during a sheathing process.

The release tab 184 of the trigger safety 142 allows for simple andconvenient release of the trigger safety 142 from engagement around theouter supports 110. In the illustrated embodiment, the release tab 184is a tongue-like projection extending away from the body 182 andoriented substantially at a tangent to the ring-like body 182. Therelease tab 184 may be coupled to the body 182 by one or more hingedextensions 190. The hinged extensions 190 may include a hinge 192 toallow the hinged extensions 190 and the release tab 184 to rotate awayfrom the body 182. The release tab 184 may engage a projection 194 onthe body 182 so as to maintain the body 182 in a closed position. Asshown in FIG. 13C, lifting or pulling the release tab 184 away from thebody 182 may cause the hinged extensions 190 and the release tab 184 torotate away from the body 182. As the release tab 184 rotates away fromthe body 182, the release tab 184 disengages from the projection 194 andallows the body 182 to open. Once the trigger safety 142 is open, it canbe removed from the outer supports 110 to allow operation of the triggerassembly 102.

FIGS. 14A-14H are views of the panchor 128 of the stent delivery system100, according to one embodiment of the present disclosure. The panchorincludes a base segment 230 and one or more extension segments 232. FIG.14A is a perspective view of a base segment 230. The base segment 230alone can function as a panchor, by itself, according to one embodiment.FIG. 14B is a perspective view of the panchor 128 of the stent deliverysystem 100 and illustrates an extension segment 232 coupled to the basesegment 230. FIG. 14C is a side view of the panchor 128. FIG. 14D is atop view and FIG. 14E is a bottom exploded view of the panchor 128.FIGS. 14F and 14G are end views of the panchor 128. FIG. 14H is across-sectional view of the panchor 128.

Referring to FIGS. 14A-14H, collectively, the panchor 128 may include apush surface 196 and one or more anchors 198. The push surface 196 maybe oriented orthogonal to an outer surface of the base segment 230. Forexample, the push surface 198 may be disposed on a flange positionedannularly around the base segment 230. The push surface 196 isconfigured to restrict proximal movement of the stent 10 as the outersheath 126 is pulled proximally over the stent 10 during deployment. Theanchors 198 may include a flange at a distal end of the base segment 230and/or the distal end of the one or more extension segments 232 of thepanchor 128. In the illustrated embodiment, the anchors 198 may includea plurality (e.g., five) of protrusions or apices about thecircumference of a distal end of the base segment 230 and/or one or moreextension segments 232. For example, the anchors 198 may be a pentagonshaped annular flange having five apices. The protrusions of each anchor198 may be configured to be positioned between connectors of the stent10 that interconnect annular segments (or rows of struts or strut arms)in the scaffolding of structure of the stent 10. For example, theanchors 198 may be arranged radially to be positioned circumferentiallybetween the connectors of a stent 10. The anchors 198 may engage thedistal ends of the struts and thereby engage the stent to limit distalmovement of the stent relative to the panchor 128.

Engagement of the struts by the anchors 198 of the panchor 128 mayrestrict distal movement of the stent 10, so long as the proximal end ofthe stent 10 remains sheathed within the pod 134 and compressed aroundthe panchor 128. One or more deflectable tabs 129 may be positioned atan opening within the panchor 128. The deflectable tabs 129 may beconfigured to deflect (e.g., spread apart) in response to contact with atapered or ramped surface of a barb of a connection member that couplesthe distal inner segment to the distal end of the inner member 122 (seee.g., FIG. 3). The deflectable tabs 129 may retract to abut theorthogonal surface(s) of the barb and thereby restrict passage of thebarb back out of the opening within the panchor 128, thereby securingthe barb in place.

The plurality of segments 128, namely the base segment 230 and one ormore extension segments 232, may be rotatably and/or flexibly coupled toenable the panchor 128 to be flexible. In the illustrated embodiment,the segments 230, 232 may comprise ball 234 and socket 236 connections.A ball 234 at a proximal end of the extension segments 232 fits into andis received by a socket 236 at the distal end of the base segment 230 oranother extension segment 232. The ball 234 and socket 236 connectionallows the segments 230, 232 to bend and rotate relative to each other.An embodiment of a panchor 128 having a plurality of extension segments232 in a curved configuration is shown in FIG. 18C.

FIGS. 15A-15C are views of a tip insertion funnel 208 of the stentdelivery system of FIG. 1. FIGS. 15A and 15B illustrate the tipinsertion funnel 208 in a closed state and FIG. 15C illustrates the tipinsertion funnel 208 in an open state. The tip insertion funnel 208 mayform a large opening 260 at a distal end that tapers to a small opening262 configured to guide the distal inner segment 136 into the panchor128. Specifically, the tip insertion funnel 208 may precisely guide theproximal end of the distal inner segment 136 retrograde through a valveof a stent to avert undesired contact and/or damage, for example, toleaflets of the valve or other portion of the valve, as a result ofimprecise insertion of the distal inner segment 136.

In the illustrated embodiment, the tip insertion funnel 208 may comprisetwo halves 242 a, 242 b and hinges 244 at a distal end of the tipinsertion funnel 208, near the larger distal opening 260. The hinges 244hingedly couple the halves 242 a, 242 b together. The hinges 242 may bedisposed in a rim 246 around the outer circumference of the distalopening of the tip insertion funnel 208. The hinges 242 may allow thetip insertion funnel 208 to open as shown in FIG. 15C and to bewithdrawn over the tip 132 (see e.g., FIG. 3) for removal afterinsertion of the distal inner segment 136 into the panchor 128. The tipinsertion funnel 208 may include removal features 248 (e.g. fingergrips) to aid in removing the tip insertion funnel 208. In theillustrated embodiment, a removal feature 248 is disposed on each of thehalves 242 a, 242 b on the distal side of the rim 246. The removalfeatures are configured to be squeezed together to rotate the halves 242a, 242 b relative to each other about the hinges 244 to open the tipinsertion funnel 208.

FIGS. 16A-16B are perspective views of a stent delivery system 1000having three triggers, according to another embodiment of the presentdisclosure. FIG. 16A is a perspective view of the stent delivery system1000 in a partially sheathed configuration. FIG. 16B is a perspectiveview of the stent delivery device 1001 in a fully sheathed deliveryconfiguration. Referring generally and collectively to FIGS. 16A-16B,the stent delivery system 1000 has three triggers 1002, 1004, 1006 thata practitioner can manipulate to retract an outer sheath 1026 and pod1034 to deploy a stent 20. The stent 20 may have a longer length, forexample 150 mm, that may be more easily deployed with a three-stage,three-trigger deployment mechanism.

Other components of the stent delivery system 1000 may be substantiallysimilar to the components of stent delivery system 100 described indetail above. The three triggers 1002, 1004, and 1006 may be operatedsequentially, each to partially deploy the stent 20. The first trigger1002 may be pulled proximally, toward a handle 1008, to partially deploythe stent 20. A second trigger 1004 may then be pulled proximally,toward the handle 1008 and the first trigger 1002, to further deploy thestent 20. Finally, a third trigger 1006 may be pulled proximally, towardthe handle 1008, the first trigger 1002, and the second trigger 1004, tocomplete deployment of the stent 20. A trigger safety 142 may limitproximal movement of the third trigger 1006 (and also limit proximalmovement of the first trigger 1002 and second trigger 1004), therebyrestricting deployment of the stent 20. The trigger safety 142 mayoperate by engaging outer supports 1010 and an internal connector (notshown) similar to the manner previously described.

The first trigger 1002 may include an annular base configured toencircle the outer supports 1010 and one or more finger holds. The firsttrigger 1002 couples to the second trigger 1004, such that proximalmovement of the first trigger 1002 results in proximal movement of thesecond trigger 1004. The second trigger 1004 may be substantiallysimilar in structure, function, and/or operation to the proximal trigger114 of the stent delivery system 100 described above. The third trigger1006 may be substantially similar in structure, function, and/oroperation to the distal trigger 116 described above. Moreover, thecoupling and operation of the second trigger 1004 and the third trigger1006 may be substantially similar to the proximal trigger 114 and distaltrigger 116 of the stent delivery system 100, as described above.

The sheathing mechanism 201 may be used to sheath the stent 20.Sheathing of the stent 20, by a sheathing action to transition the stentdelivery system 1000 from the partially sheathed configuration to thefully sheathed delivery configuration, may be accomplished in much thesame way as described above. As can be appreciated, the sheathingfingers of the sheathing mechanism 201 may have a longer length toaccommodate a longer stent. Similarly, the sheathing mechanism 201 maybe longer.

FIGS. 17A and 17B are side and top cross-sectional views, respectively,of an internal connector 1020, a third trigger 1006, a floater 1018, asecond trigger 1004, floater arms 1012, and a first trigger 1002 of thestent delivery system of FIGS. 16A and 16B. FIG. 17A is a side view andFIG. 17B is a top sectional view illustrating the coupling relationshipof the first trigger 1002, the second trigger 1004, a floater 1018, aninternal connector 1020, and the third trigger 1006. The floater 1018and internal connector 1020 may be substantially similar in structure,function, and/or operation to the floater 118 and internal connector 120of stent delivery system 100 of FIG. 1, described above. The couplingand operation of the second trigger 1004, the floater 1018, the internalconnector 1020, and the third trigger 1006 may be substantially similarto the corresponding components of the stent delivery system 100, asdescribed above with reference to FIGS. 11A and 11B.

Referring collectively to FIGS. 17A and 17B, the third trigger 1006couples to the internal connector 1020. In the illustrated embodiment,one or more outwardly extending protrusions 1052 on the internalconnector 1020 mate with trigger guides on the third trigger 1006. Asthe third trigger 1006 is retracted proximally, toward the handle 1008(FIG. 16A), the third trigger 1006 retracts the internal connector 1020proximally. Thus, retraction of the third trigger 1006 results inretraction of the outer sheath 1026 and pod 1034 (FIG. 16A), whichresults in at least partial deployment of a stent 20 sheathed within thepod 1034.

The second trigger 1004 is mechanically coupled to the third trigger1006 by the floater 1018. In the illustrated embodiment, the floater1018 engages a floater engagement ring (coupled to inwardly protrudingtrigger guides) of the second trigger 1004. The floater engagement ringengages the proximal end of the floater 1018 such that proximal movementof the second trigger 1004 retracts the floater 1018. The distal end ofthe floater engages the third trigger 1006 and/or the internal connector1020. Accordingly, retraction of the second trigger 1004 results inretraction of the third trigger 1006 and/or the internal connector 1020,which retracts the outer sheath 1026 and pod 1034 and at least partiallydeploys a sheathed stent 20.

The first trigger 1002 includes one or more barbed external floater arms1012 that may extend distally from the base of the first trigger 1002 toengage the second trigger 1004. Barbs 1014 at the distal end of theexternal floater arms 1012 may engage a base of the second trigger 1004as the first trigger 1002 moves proximally, while allowing distalmovement of the first trigger 1002 relative to the second trigger 1004.Stated differently, the barbed engagement arms 1002 allow the secondtrigger 1004 to move proximally relative to the first trigger 1002, suchthat the second trigger 1004 can be operated and retracted toward thefirst trigger 1002, even after the first trigger 1002 has beenretracted.

FIGS. 18A-18C are views of the panchor 1028 of the stent delivery system1000. The panchor includes a base segment 1130 and a plurality ofextension segments 1132 a, 1132 b, 1132 c, 1132 d, 1132 e (collectively1132). FIG. 18A is a side view of the panchor 1028. FIG. 18B is a sidecross-sectional view of the panchor 1028. FIG. 18C is a sidecross-sectional view illustrating flexibility of the panchor 1028.

Referring to FIGS. 18A-18C, collectively, the panchor 1028 may include apush surface 1096 and one or more anchors 1098. The push surface 1096 isconfigured to restrict proximal movement of the stent 20 as the outersheath 1026 is pulled proximally over the stent 20 during deployment.The anchors 1098 may include a flange at a distal end of the basesegment 1130 and/or the distal end of the one or more extension segments1132 of the panchor 1028. In the illustrated embodiment, the anchors1098 may include a plurality (e.g., five) of protrusions or apices aboutthe circumference of a distal end of the base segment 1130 and/or one ormore extension segments 1132. The protrusions of each anchor 1098 areconfigured to be positioned between connectors of the stent 20 thatinterconnect annular segments (or rows) of struts in the scaffolding ofstructure of the stent 20 to engage the distal ends of the struts.Engagement of the struts by the anchors 1098 of the panchor 1028restricts distal movement of the stent 20, so long as the engagedportion of the stent 20 remains sheathed within the pod 1034 andcompressed around the panchor 1028.

The plurality of segments of the panchor 1028, namely the base segment1130 and the extension segments 1132, may be rotatably and/or flexiblycoupled to enable the panchor 1028 to be flexible. In the illustratedembodiment, the segments 1130, 1132 comprise ball 1134 and socket 1136connections. A ball 1134 at a proximal end of the extension segments1132 fits into and is received by a socket 1136 at the distal end of thebase segment 1130 or another extension segment 1132. The ball 1134 andsocket 1136 connection allows the segments 1130, 1132 to bend and rotaterelative to each other. FIG. 18C illustrates the panchor 1028 having aplurality of extension segments 1132 in a curved configuration.

In the illustrated embodiment, the first extension segment 1132 a may beslightly longer than the other extension segments 1132 b, 1132 c, 1132d, 1132 e. The length of any of the extension segments 1132 and/or thebase member 1130 may be adjusted according to the design and/orconfiguration of a stent to be deployed. Moreover, the number ofprotrusions on the plurality of anchors 1098 may vary according to thedesign and/or configuration of a stent to be deployed.

FIG. 19 is a perspective view of the stent delivery system 100 of FIG. 1packaged in a storage configuration, according to one embodiment.

As can be appreciated, other embodiments are possible in whichadditional triggers, beyond three, are coupled together in a similarmanner as described herein.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. As can be appreciated by those having skill in theart, many changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention. The scope of the invention is, therefore, indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

What is claimed is:
 1. A delivery system for sheathing a crimpableimplantable device and deploying the implantable device within a body ofa patient, the delivery system comprising: a delivery device to positionand deploy the implantable device, the delivery device including atubular member, the tubular member including an outer sheath and a poddisposed at a distal portion of the outer sheath, the pod configured toreceive and house the implantable device in a crimped state for deliveryto a target location within the body of the patient, the delivery devicehaving a partially sheathed configuration, a fully sheathed deliveryconfiguration, and a deployed configuration; and a sheathing mechanismthat engages the tubular member of the delivery device, the sheathingmechanism including a ramped surface and a tapered member, the rampedsurface to be disposed at a distal end of the outer sheath of thetubular member to collapse inwardly and compress the implantable device,the tapered member to be moved in a distal direction along the tubularmember, wherein distal movement of the tapered member of the sheathingmechanism relative to the delivery device results in interaction of thetapered member and the ramped surface to crimp the implantable deviceand moves the outer sheath of the tubular member distally relative to acrimped portion of the implantable device to transition the deliverydevice from the partially sheathed configuration to the fully sheatheddelivery configuration to sheathe the implantable device, wherein thedistal movement of the tapered member causes distal movement of theramped surface, and wherein the distal movement of the ramped surface isconfigured to pull the pod over the implantable device in the crimpedstate.
 2. The delivery system of claim 1, wherein the sheathingmechanism comprises: a plurality of sheathing fingers to crimp anunsheathed portion of the implantable device, the plurality of sheathingfingers comprising the ramped surface; and a translational member thatis axially displaceable relative to the tubular member of the deliverydevice, the translational member comprising the tapered member disposedat a distal end of the translational member to interact with theplurality of sheathing fingers and translate axial movement of thetranslational member in a distal direction along the tubular member intoradial force to compress and thereby crimp the unsheathed portion of theimplantable device.
 3. The delivery system of claim 2, wherein theplurality of sheathing fingers are configured to engage the outer sheathof the tubular member of the delivery device and to engage thetranslational member as the translational member is moved distally alongthe tubular member of the delivery device, wherein distal movement ofthe translational member moves the outer sheath of the tubular memberdistally relative to a crimped portion of the implantable device tothereby sheathe the crimped portion of the implantable device.
 4. Thedelivery system of claim 2, wherein the tubular member of the deliverydevice comprises: an inner member to couple to the implantable device inthe partially sheathed configuration and the fully sheathed deliveryconfiguration; and wherein the outer sheath coaxially surrounds a distalportion of the inner member, wherein the outer sheath has a distalportion configured to enclose the implantable device in the fullysheathed delivery configuration, and wherein the outer sheath isslidably moveable relative to the inner member and proximal movement ofthe outer sheath relative to the inner member deploys the implantabledevice.
 5. The delivery system of claim 4, wherein the sheathingmechanism further comprises a tip insertion funnel to guide coupling ofa tip to the inner member, wherein the tip is coupled to a distalsegment of the inner member that is configured to couple to the innermember, wherein the distal segment comprises an elongate shaft, andwherein the tip insertion funnel guides the distal segment through alumen of the implantable device to couple to the inner member of thetubular member of the delivery device.
 6. The delivery system of claim5, wherein the tip insertion funnel comprises two halves coupledtogether by hinges disposed at a distal rim of the tip insertion funnel,wherein the hinges allow the tip insertion funnel to have an openedstate and a closed state.
 7. The delivery system of claim 4, wherein theplurality of sheathing fingers are configured to engage the outer sheathof the tubular member of the delivery device and to engage thetranslational member as the translational member is moved distally alongthe tubular member of the delivery device, wherein distal movement ofthe translational member causes distal movement of the sheathingfingers, which thereby moves the outer sheath of the tubular memberdistally relative to the inner member and a crimped portion of theimplantable device to thereby sheathe the crimped portion of theimplantable device.
 8. The delivery system of claim 7, wherein theplurality of sheathing fingers are configured to engage and move the podas the sheathing fingers are moved distally relative to the innermember.
 9. The delivery system of claim 8, wherein the delivery devicefurther comprises a transition configured to couple the outer sheath andthe pod, the transition molded to comprise a proximal end and a distalend, the proximal end having a smaller outer diameter approximatelyequal to a diameter of the outer sheath, the distal end having a largerouter diameter larger than the proximal end and approximately equal to adiameter of the pod.
 10. The delivery system of claim 9, wherein the podis formed of two or more sheath layers including an outer sheath layerand one or more remaining sheath layers disposed coaxially within theouter sheath layer, and wherein the outer sheath layer of the pod isconfigured to be disposed over a distal portion of the transition. 11.The delivery system of claim 10, wherein the two or more sheath layersof the pod are fused together and fused to the transition by reflowingand form a wall of the pod.
 12. The delivery system of claim 9, whereinthe outer sheath is formed of two or more layers, including an outerlayer and one or more remaining layers disposed coaxially within theouter layer, and wherein the outer layer of the outer sheath isconfigured to be disposed over a proximal portion of the transition. 13.The delivery system of claim 12, wherein the two or more layers of theouter sheath are fused together and fused to the transition byreflowing.
 14. The delivery system of claim 1, wherein the implantabledevice comprises a metal scaffolding structure formed of a plurality ofrows of struts oriented about a longitudinal axis to define an outercircumference of the implantable device and connected by a plurality ofconnectors extending longitudinally with the longitudinal axis of theimplantable device.
 15. The delivery system of claim 1, wherein theimplantable device is a stent comprising a valve and the partiallysheathed configuration of the delivery device positions the valve in anunsheathed portion of the stent.
 16. The delivery system of claim 1,wherein the target location within the body of the patient is within alumen.
 17. A delivery system for sheathing a stent and deploying thestent within a body of a patient, the delivery system comprising: acrimpable stent formed of a shape memory material; a delivery device toposition and deploy the stent within the body, the delivery deviceincluding a tubular member, the tubular member including an outer sheathand a pod disposed at a distal portion of the outer sheath, the podconfigured to receive and house the stent in a crimped state fordelivery to a target location within the body of the patient, thedelivery device having a partially sheathed configuration, a fullysheathed delivery configuration, and a deployed configuration; and asheathing mechanism configured to engage the tubular member of thedelivery device, the sheathing mechanism including a ramped surface anda tapered member, the ramped surface to be disposed at a distal end ofthe outer sheath of the tubular member to collapse inwardly and compressthe stent, the tapered member to be moved in a distal direction alongthe tubular member, wherein distal movement of the tapered member of thesheathing mechanism relative to the delivery device results ininteraction of the tapered member and the ramped surface to crimp thestent and moves the outer sheath of the tubular member distally relativeto a crimped portion of the stent to sheathe the stent as the deliverydevice transitions from the partially sheathed configuration to thefully sheathed delivery configuration, wherein the distal movement ofthe tapered member causes distal movement of the ramped surface, andwherein the distal movement of the ramped surface is configured to pullthe pod over the stent in the crimped state.
 18. The delivery system ofclaim 17, wherein the sheathing mechanism comprises: a plurality ofsheathing fingers each having a flared portion including the rampedsurface and a base portion, the flared portions configured to extenddistally from the base portion and beyond a distal end of the outersheath and extend along a length of an unsheathed portion of the stent,such that the flared portions are arranged about an outer diameter ofthe unsheathed portion of the stent, wherein the flared portions areconfigured to crimp the unsheathed portion of the stent as they aredrawn into the sheathing mechanism, the base portions configured toengage and move a portion of the tubular member of the delivery devicedistally over a crimped portion of the stent to sheathe the stent as thebase portions are moved distally relative to the stent; and atranslational member that is axially displaceable relative to thetubular member of the delivery device, the translational membercomprising the tapered member disposed at a distal end of thetranslational member to interact with the plurality of sheathing fingersand translate axial movement of the translational member in a distaldirection along the tubular member into radial force to compress andthereby crimp the stent, the translational member configured to engageand move the plurality of sheathing fingers distally relative to thestent as the translational member is moved in the distal direction alongthe tubular member.
 19. The delivery system of claim 18, wherein thetranslational member of the sheathing mechanism comprises: a sheathingtube having a lumen there through with an inner diameter configured tobe positioned over an outer diameter of the distal portion of the outersheath of the delivery device, wherein the sheathing tube is slidablymoveable relative to the outer sheath; and a sheathing funnel disposedat a distal end of the sheathing tube, the sheathing funnel comprisingthe tapered member, the sheathing funnel having an internal taper andribs that interact with the plurality of sheathing fingers and the stentduring sheathing to guide the stent and the plurality of sheathingfingers into the sheathing tube to crimp the stent.
 20. The deliverysystem of claim 17, wherein the stent comprises a metal scaffoldingstructure that does not substantially elongate when crimped and thatincludes a valve.
 21. The delivery system of claim 20, wherein thescaffolding structure of the stent is formed of a plurality of rows ofstruts oriented about a longitudinal axis to define an outercircumference of the stent and connected by a plurality of connectorsextending longitudinally with the longitudinal axis of the stent. 22.The delivery system of claim 17, wherein the tubular member of thedelivery device comprises: an inner member to couple to the stent in thecrimped state; and wherein the outer sheath coaxially surrounds a distalportion of the inner member, wherein the outer sheath has a distalportion configured to enclose the stent in the fully sheathed deliveryconfiguration, and wherein the outer sheath is slidably moveablerelative to the inner member and proximal movement of the outer sheathrelative to the inner member deploys the stent.
 23. The delivery systemof claim 22, wherein the tubular member of the delivery device furthercomprises: a transition molded to comprise a proximal end having asmaller outer diameter approximately equal to an outer diameter of theouter sheath and a distal end having a larger outer diameter larger thanthe proximal end and approximately equal to an outer diameter of thepod, the pod having an outer diameter that is larger than the outerdiameter of the outer sheath, the transition configured to couple theouter sheath and the pod.
 24. The delivery system of claim 22, whereinthe inner member of the tubular member of the delivery device furthercomprises: a panchor configured to couple to a proximal portion of thestent in a partially sheathed configuration and a fully sheatheddelivery configuration, wherein the panchor is a combination pusher andanchor configured to limit proximal and distal movement of the stent.25. A method for deploying an implantable device at a target locationwithin a body of a patient, the method comprising: positioning asheathing mechanism at a distal region of a tubular member of a deliverydevice, the sheathing mechanism comprising a plurality of sheathingfingers to engage an outer sheath of the tubular member and atranslational member that is axially displaceable relative to thetubular member of the delivery device and relative to the plurality ofsheathing fingers and that interacts with the plurality of sheathingfingers to translate axial movement of the translational member in adistal direction along the tubular member into radial force to compressand thereby crimp the implantable device, wherein the delivery device isin a partially sheathed configuration having an implantable devicepartially unsheathed and partially sheathed at a distal end of thetubular member; grasping with a first hand the translational member ofthe sheathing mechanism; grasping with a second hand the deliverydevice; advancing the translational member of the sheathing mechanism ina distal direction with the first hand, and away from the second handgrasping the delivery device, while restraining distal movement of thedelivery device, thereby moving the plurality of sheathing fingers ofthe sheathing mechanism distally relative to the implantable device andover the implantable device and causing the sheathing mechanism totranslate axial distal movement along the tubular member into radialforce that compresses and thereby crimps the implantable device and tomove the distal region of the outer sheath of the tubular member of thedelivery device over the crimped implantable device to fully sheathe theimplantable device; positioning the distal region of the tubular memberof the delivery device with the crimped and sheathed implantable devicewithin the body of the patient at a target location; and deploying theimplantable device from the delivery device at the target location. 26.The method of claim 25, further comprising: positioning a guidewirethrough a lumen of the body of the patient to the target location,wherein positioning the distal region of the tubular member of thedelivery device within the body of the patient and at a target locationcomprises advancing the delivery, including the implantable device, overthe guidewire.
 27. The method of claim 25, further comprising: removingthe sheathing mechanism from the distal region of the tubular member ofa delivery device after advancing the sheathing mechanism in the distaldirection to fully sheathe the implantable device.
 28. The method ofclaim 25, wherein the translational member comprises a lumen with aninner diameter configured to be positioned around an outer diameter ofthe distal region of the tubular member of the delivery device, whereinpositioning the sheathing mechanism includes positioning the sheathingmechanism such that the tubular member of the delivery device ispositioned through the lumen of the translational member.
 29. The methodof claim 28, wherein the sheathing mechanism comprises: a sheathing tubeforming the lumen of the sheathing mechanism, wherein the sheathing tubeis slidably moveable relative to the outer sheath of the tubular memberof the delivery device; and a sheathing funnel disposed at a distal endof the sheathing tube, the sheathing funnel having an internal taper andribs that interact with the plurality of sheathing fingers and theimplantable device during sheathing to guide the plurality of sheathingfingers into the sheathing tube and to crimp the implantable device, andwherein positioning the sheathing mechanism further comprises:positioning the sheathing tube and sheathing funnel over the distalregion of the tubular member of the delivery device; and arranging theplurality of sheathing fingers around and in engagement with the outersheath at the distal region of the tubular member of the delivery deviceand with flared portions of the sheathing fingers disposed around theouter diameter of the unsheathed portion of the implantable device,wherein the sheathing tube is configured to engage the sheathing fingersof the sheathing mechanism to move the outer sheath over the crimpedimplantable device as the sheathing tube is moved distally relative toand over the implantable device to sheath the implantable device. 30.The method of claim 25, wherein positioning the sheathing mechanismfurther comprises inserting a distal inner segment through a lumen ofthe implantable device to couple to an inner member of the deliverydevice, wherein a tip is coupled to the distal inner segment.
 31. Themethod of claim 30, wherein positioning the sheathing mechanism furthercomprises coupling a tip insertion funnel to a distal end of theplurality of sheathing fingers, wherein the tip insertion funnel isconfigured to guide insertion of the distal inner segment through thelumen of the implantable device.